Purpose

This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information. - female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy. -≥ 40 years of age - ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60 - Histologically or cytologically confirmed invasive breast carcinoma. - tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results. - Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0). - The following staging criteria must be met according to AJCC 8th edition criteria: Adjuvant cohort : By pathologic evaluation, the patient's primary tumor must be </= 2 cm and ipsilateral nodes must be pN0. Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor). Neoadjuvant cohort: Prior to neoadjuvant therapy, the patient's primary tumor must be < 3 cm by imaging studies, with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination is not sufficient documentation of cN0 status; • Must be ypT0N0 at surgery (lumpectomy); patients with residual non-invasive disease (DCIS) in the surgical specimen (ypTis), are NOT eligible. - For the Adjuvant cohort, adjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy. - For the Neoadjuvant cohort, neoadjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.- ; Patients who did not receive chemotherapy in the neoadjuvant setting are not eligible, even if they achieved pCR with their preoperative treatment; nor would these patients become eligible by receiving chemotherapy after surgery. - In patients assigned to radiation therapy, treatment should start ≤ 12 weeks from surgery on the Neoadjuvant cohort and ≤ 8 weeks from the completion of chemotherapy on the Adjuvant cohort. Patients should continue HER2-targeted therapy during assigned study treatment (radiation or observation). - Bilateral mammogram or MRI within 52 weeks prior to randomization. - HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.

Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease. - On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination. - Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease. - Patient planning for or status-post mastectomy. - Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease. - Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign. - Non-epithelial breast malignancies such as sarcoma or lymphoma. - Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by > 4 centimeters. If multifocal, all foci should be confined to a maximum tumor bed of 3 cm determined by pathological assessment. - Paget's disease of the nipple. - Synchronous (unilateral or bilateral) invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) - On the Adjuvant cohort, surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible). - Treatment plan that includes regional nodal irradiation. - Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥ 10 years prior to enrollment is permissible. - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. - Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to randomization. - Prior ipsilateral breast or thoracic RT for any condition (contralateral RT for DCIS ≥ 10 years prior to randomization is permitted). - Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma. - Clinicians should consider whether any conditions would make this protocol unreasonably hazardous for the patient. - Pregnancy or lactation at the time of randomization or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for patients of childbearing potential must be performed within 14 days prior to randomization.) - Use of any investigational product within 30 days prior to randomization.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects who are receiving standard of care systemic HER2-targeted therapies are randomized to standard of care adjuvant breast radiation or no breast radiation
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Adjuvant Breast Radiation
Patients continue to receive their current planned adjuvant breast radiation and systemic HER2-targeted therapies
  • Radiation: Standard of Care Adjuvant Breast Radiation
    adjuvant breast radiotherapy per the current standard of care
Active Comparator
Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
Patients continue to receive their current systemic HER2-targeted therapy without breast adjuvant radiation
  • Drug: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
    participants are randomized to continue their standard of care systemic HER2-targeted therapy without adjuvant breast radiotherapy

Recruiting Locations

Cancer Center at Saint Joseph's
Phoenix 5308655, Arizona 5551752 85004
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Banner University Medical Center - Tucson
Tucson 5318313, Arizona 5551752 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson 5318313, Arizona 5551752 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro 4116834, Arkansas 4099753 72401
Contact:
Site Public Contact
870-936-7066
Emily.Carvell@bmhcc.org

Kaiser Permanente-Deer Valley Medical Center
Antioch 5324200, California 5332921 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande 5324802, California 5332921 93420
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Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

PCR Oncology
Arroyo Grande 5324802, California 5332921 93420
Contact:
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702-384-0013
research@sncrf.org

Sutter Auburn Faith Hospital
Auburn 5325223, California 5332921 95602
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Site Public Contact
clinicalresearch@sutterhealth.org

Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn 5325223, California 5332921 95603
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clinicalresearch@sutterhealth.org

Tower Cancer Research Foundation
Beverly Hills 5328041, California 5332921 90211
Contact:
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towercancerresearch@toweroncology.com

Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park 5333282, California 5332921 95682
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clinicalresearch@sutterhealth.org

City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
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800-826-4673
becomingapatient@coh.org

Kaiser Permanente Dublin
Dublin 5344157, California 5332921 94568
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877-642-4691

Kaiser Permanente-Fremont
Fremont 5350734, California 5332921 94538
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877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Fremont
Fremont 5350734, California 5332921 94538
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Site Public Contact
clinicalresearch@sutterhealth.org

Fresno Cancer Center
Fresno 5350937, California 5332921 93720
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Fresno
Fresno 5350937, California 5332921 93720
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877-642-4691
Kpoct@kp.org

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine 5359777, California 5332921 92612
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877-827-8839
ucstudy@uci.edu

City of Hope at Irvine Lennar
Irvine 5359777, California 5332921 92618
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877-467-3411

City of Hope Antelope Valley
Lancaster 5364940, California 5332921 93534
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800-826-4673
becomingapatient@coh.org

Los Angeles General Medical Center
Los Angeles 5368361, California 5332921 90033
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323-865-0451
uscnorrisinfo@med.usc.edu

USC / Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
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323-865-0451

Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
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Site Public Contact
310-423-8965

Memorial Medical Center
Modesto 5373900, California 5332921 95355
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clinicalresearch@sutterhealth.org

Kaiser Permanente-Modesto
Modesto 5373900, California 5332921 95356
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877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Camino Division
Mountain View 5375480, California 5332921 94040
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clinicalresearch@sutterhealth.org

Kaiser Permanente Oakland-Broadway
Oakland 5378538, California 5332921 94611
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877-642-4691
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Kaiser Permanente-Oakland
Oakland 5378538, California 5332921 94611
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877-642-4691
Kpoct@kp.org

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
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877-827-8839
ucstudy@uci.edu

Palo Alto Medical Foundation Health Care
Palo Alto 5380748, California 5332921 94301
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clinicalresearch@sutterhealth.org

Stanford Cancer Institute Palo Alto
Palo Alto 5380748, California 5332921 94304
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650-498-7061
ccto-office@stanford.edu

Pomona Valley Hospital Medical Center
Pomona 5384170, California 5332921 91767
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909-865-9555

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova 5385941, California 5332921 95670
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877-642-4691
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Kaiser Permanente- Marshall Medical Offices
Redwood City 5386834, California 5332921 94063
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877-642-4691

Kaiser Permanente-Richmond
Richmond 5387428, California 5332921 94801
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877-642-4691
Kpoct@kp.org

Rohnert Park Cancer Center
Rohnert Park 5388564, California 5332921 94928
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville 5388881, California 5332921 95661
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877-642-4691
Kpoct@kp.org

Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville 5388881, California 5332921 95661
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clinicalresearch@sutterhealth.org

Sutter Roseville Medical Center
Roseville 5388881, California 5332921 95661
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clinicalresearch@sutterhealth.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville 5388881, California 5332921 95678
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877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento 5389489, California 5332921 95814
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877-642-4691
kpoct@kp.org

Sutter Medical Center Sacramento
Sacramento 5389489, California 5332921 95816
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Site Public Contact
clinicalresearch@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
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916-734-3089

Kaiser Permanente-South Sacramento
Sacramento 5389489, California 5332921 95823
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877-642-4691
Kpoct@kp.org

South Sacramento Cancer Center
Sacramento 5389489, California 5332921 95823
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877-642-4691
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California Pacific Medical Center-Pacific Campus
San Francisco 5391959, California 5332921 94115
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Site Public Contact
clinicalresearch@sutterhealth.org

Kaiser Permanente-San Francisco
San Francisco 5391959, California 5332921 94115
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Teresa-San Jose
San Jose 5392171, California 5332921 95119
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877-642-4691
Kpoct@kp.org

Stanford Cancer Center South Bay
San Jose 5392171, California 5332921 95124
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650-498-7061
ccto-office@stanford.edu

Kaiser Permanente San Leandro
San Leandro 5392263, California 5332921 94577
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877-642-4691
Kpoct@kp.org

Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo 5392323, California 5332921 93401
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720-874-1881
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Kaiser San Rafael-Gallinas
San Rafael 5392567, California 5332921 94903
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877-642-4691
Kpoct@kp.org

Ridley-Tree Cancer Center
Santa Barbara 5392952, California 5332921 93105
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clinicalresearch@sutterhealth.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara 5393015, California 5332921 95051
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877-642-4691
Kpoct@kp.org

Mission Hope Medical Oncology - Santa Maria
Santa Maria 5393180, California 5332921 93444
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720-874-1881
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Kaiser Permanente-Santa Rosa
Santa Rosa 5393287, California 5332921 95403
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877-642-4691
Kpoct@kp.org

Sutter Pacific Medical Foundation
Santa Rosa 5393287, California 5332921 95403
Contact:
Site Public Contact
415-209-2683
clinicalresearch@sutterhealth.org

City of Hope South Pasadena
South Pasadena 5397717, California 5332921 91030
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Site Public Contact
800-826-4673
becomingapatient@coh.org

Kaiser Permanente Cancer Treatment Center
South San Francisco 5397765, California 5332921 94080
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-South San Francisco
South San Francisco 5397765, California 5332921 94080
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton 5399020, California 5332921 95210
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877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale 5400075, California 5332921 94086
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Site Public Contact
clinicalresearch@sutterhealth.org

Cedars-Sinai Cancer - Tarzana
Tarzana 5401143, California 5332921 91356
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818-981-3818

City of Hope South Bay
Torrance 5403022, California 5332921 90503
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877-467-3411

Torrance Memorial Physician Network - Cancer Care
Torrance 5403022, California 5332921 90505
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310-750-3300
courtney.steeneken@tmphysicians.com

City of Hope Upland
Upland 5404915, California 5332921 91786
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800-826-4673
becomingapatient@coh.org

Kaiser Permanente Medical Center-Vacaville
Vacaville 5405228, California 5332921 95688
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo 5405380, California 5332921 94589
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877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek 5406990, California 5332921 94596
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877-642-4691
Kpoct@kp.org

UCHealth University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
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Site Public Contact
720-848-0650

Penrose-Saint Francis Healthcare
Colorado Springs 5417598, Colorado 5417618 80907
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Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Rocky Mountain Cancer Centers-Penrose
Colorado Springs 5417598, Colorado 5417618 80907
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720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UCHealth Memorial Hospital Central
Colorado Springs 5417598, Colorado 5417618 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs 5417598, Colorado 5417618 80920
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719-364-6700

Saint Francis Cancer Center
Colorado Springs 5417598, Colorado 5417618 80923
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Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Poudre Valley Hospital
Fort Collins 5577147, Colorado 5417618 80524
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Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins 5577147, Colorado 5417618 80528
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Site Public Contact
412-339-5294
Roster@nrgoncology.org

UCHealth Greeley Hospital
Greeley 5577592, Colorado 5417618 80631
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412-339-5294
Roster@nrgoncology.org

UCHealth Highlands Ranch Hospital
Highlands Ranch 5425043, Colorado 5417618 80129
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Site Public Contact
720-848-0650

Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538
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Site Public Contact
970-203-7083

John Fitzgerald Kennedy Medical Center
Atlantis 4146372, Florida 4155751 33462
Contact:
Site Public Contact
561-964-2662

Morton Plant Hospital
Clearwater 4151316, Florida 4155751 33756
Contact:
Site Public Contact
855-314-8646

Lee Memorial Health System
Fort Myers 4155995, Florida 4155751 33901
Contact:
Site Public Contact
877-680-0008

Regional Cancer Center-Lee Memorial Health System
Fort Myers 4155995, Florida 4155751 33905
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Sarasota Memorial Hospital-Venice
N. Venice, Florida 4155751 34275
Contact:
Site Public Contact
941-261-9000

GenesisCare USA - Plantation
Plantation 4168782, Florida 4155751 33324
Contact:
Site Public Contact
941-833-5700
Rudi.Ross@usa.genesiscare.com

Florida Cancer Specialists - Sarasota
Sarasota 4172131, Florida 4155751 34232
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Site Public Contact
412-339-5294
Roster@nrgoncology.org

Intercoastal Medical Group - Cattleridge II
Sarasota 4172131, Florida 4155751 34232
Contact:
Site Public Contact
941-200-1125

Florida Cancer Specialists - Sarasota Downtown
Sarasota 4172131, Florida 4155751 34236
Contact:
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941-957-1000

First Physicians Group - Urology Robotic and Minimally Invasive Surgery
Sarasota 4172131, Florida 4155751 34239
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941-917-5400

First Physicians Group-Sarasota
Sarasota 4172131, Florida 4155751 34239
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Site Public Contact
941-917-8383

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
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Site Public Contact
941-917-2225

Sarasota Memorial Health Care Center at University Parkway
Sarasota 4172131, Florida 4155751 34243
Contact:
Site Public Contact
941-917-6519

Moffitt Cancer Center-International Plaza
Tampa 4174757, Florida 4155751 33607
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center - McKinley Campus
Tampa 4174757, Florida 4155751 33612
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800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
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800-679-0775
ClinicalTrials@moffitt.org

Florida Cancer Specialists - Venice Pinebrook
Venice 4176380, Florida 4155751 34275
Contact:
Site Public Contact
239-274-9930
ClinicalTrials@FLCancer.com

Florida Cancer Specialists - Venice Island
Venice 4176380, Florida 4155751 34285
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412-339-5294
Roster@nrgoncology.org

Moffitt Cancer Center at Wesley Chapel
Wesley Chapel 4177727, Florida 4155751 33544
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Grady Health System
Atlanta 4180439, Georgia 4197000 30303
Contact:
Site Public Contact
404-778-1868

Emory Proton Therapy Center
Atlanta 4180439, Georgia 4197000 30308
Contact:
Site Public Contact
404-251-2854
allyson.anderson@emory.edu

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
Contact:
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888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Contact:
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404-778-1868

Emory Saint Joseph's Hospital
Atlanta 4180439, Georgia 4197000 30342
Contact:
Site Public Contact
404-851-7115

Emory Decatur Hospital
Decatur 4191124, Georgia 4197000 30033
Contact:
Site Public Contact
440-778-1868
clinicaltrialsoncology@dekalbmedical.org

Emory Johns Creek Hospital
Johns Creek 6331909, Georgia 4197000 30097
Contact:
Site Public Contact
404-778-5714
m.lisa.hwang@emory.edu

CTCA at Southeastern Regional Medical Center
Newnan 4212684, Georgia 4197000 30265
Contact:
Site Public Contact
770-400-6629

South Georgia Medical Center/Pearlman Cancer Center
Valdosta 4228147, Georgia 4197000 31602
Contact:
Site Public Contact
229-259-4628
maryann.heddon@sgmc.org

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-522-4333

University of Hawaii Cancer Center
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-586-2979

Kuakini Medical Center
Honolulu 5856195, Hawaii 5855797 96817
Contact:
Site Public Contact
808-547-9816

Queen's Cancer Center - Kuakini
Honolulu 5856195, Hawaii 5855797 96817
Contact:
Site Public Contact
808-531-8521

Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96826
Contact:
Site Public Contact
808-983-6090

Castle Medical Center
Kailua 5847486, Hawaii 5855797 96734
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue 5850248, Hawaii 5855797 96766
Contact:
Site Public Contact
808-535-7960

Hawaii Cancer Care - Westridge
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-539-2273
info@hawaiicancercare.com

Pali Momi Medical Center
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-486-6000

Queen's Cancer Center - Pearlridge
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-487-7447

The Cancer Center of Hawaii-Pali Momi
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-678-9000

The Queen's Medical Center - West Oahu
‘Ewa Beach 5855051, Hawaii 5855797 96706
Contact:
Site Public Contact
rohta@queens.org

Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Fruitland
Fruitland 5593708, Idaho 5596512 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian 5600685, Idaho 5596512 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Nampa
Nampa 5601933, Idaho 5596512 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls 5610810, Idaho 5596512 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Rush-Copley Medical Center
Aurora 4883817, Illinois 4896861 60504
Contact:
Site Public Contact
630-978-6212
RCMC_Cancer_Research@rush.edu

Centralia Oncology Clinic
Centralia 4235587, Illinois 4896861 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-864-5204

University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Elmhurst Memorial Hospital
Elmhurst 4891010, Illinois 4896861 60126
Contact:
Site Public Contact
630-758-5460
Jrohde@emhc.org

Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Glenview Outpatient Center
Glenview 4893886, Illinois 4896861 60026
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake 4894465, Illinois 4896861 60030
Contact:
Site Public Contact
312-695-1102

Ingalls Memorial Hospital
Harvey 4895298, Illinois 4896861 60426
Contact:
Site Public Contact
708-915-4673
clinicaltrials@ingalls.org

Northwestern Medicine Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
Contact:
Site Public Contact
708-226-4357

Edward Hospital/Cancer Center
Naperville 4903279, Illinois 4896861 60540
Contact:
Site Public Contact
630-646-6075

UC Comprehensive Cancer Center at Silver Cross
New Lenox 4903535, Illinois 4896861 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle Cancer Institute Normal
Normal 4903780, Illinois 4896861 61761
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Orland Park
Orland Park 4904937, Illinois 4896861 60462
Contact:
Site Public Contact
nctnprogram_rhlccc@northwestern.edu

University of Chicago Medicine-Orland Park
Orland Park 4904937, Illinois 4896861 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield 4250542, Illinois 4896861 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Midwestern Regional Medical Center
Zion 4917358, Illinois 4896861 60099
Contact:
Site Public Contact
844-793-0745

Northwest Cancer Center - Main Campus
Crown Point 4919451, Indiana 4921868 46307
Contact:
Site Public Contact
219-310-2550

UChicago Medicine Northwest Indiana
Crown Point 4919451, Indiana 4921868 46307
Contact:
Site Public Contact
855-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Northwest Oncology LLC
Dyer 4919820, Indiana 4921868 46311
Contact:
Site Public Contact
219-924-8178

Goshen Center for Cancer Care
Goshen 4920808, Indiana 4921868 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Northwest Cancer Center - Hobart
Hobart 4921476, Indiana 4921868 46342
Contact:
Site Public Contact
219-947-1795

Saint Mary Medical Center
Hobart 4921476, Indiana 4921868 46342
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

The Community Hospital
Munster 4924014, Indiana 4921868 46321
Contact:
Site Public Contact
219-836-3349

Women's Diagnostic Center - Munster
Munster 4924014, Indiana 4921868 46321
Contact:
Site Public Contact
219-934-8869
mnicholson@comhs.org

Reid Health
Richmond 4263681, Indiana 4921868 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Northwest Cancer Center - Valparaiso
Valparaiso 4927537, Indiana 4921868 46383
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

Mary Greeley Medical Center
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Ames
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-241-3305

Physicians' Clinic of Iowa PC
Cedar Rapids 4850751, Iowa 4862182 52402
Contact:
Site Public Contact
319-297-2900

Mercy Cancer Center-West Lakes
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-241-3305

Greater Regional Medical Center
Creston 4853078, Iowa 4862182 50801
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center - Des Moines
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-241-3305

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee 4880981, Iowa 4862182 50263
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center-West Lakes
West Des Moines 4881346, Iowa 4862182 50266
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

The University of Kansas Cancer Center - Olathe
Olathe 4276614, Kansas 4273857 66061
Contact:
Site Public Contact
913-588-1569
OlatheCCResearch@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park 4276873, Kansas 4273857 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Overland Park 4276873, Kansas 4273857 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Salina Regional Health Center
Salina 4278890, Kansas 4273857 67401
Contact:
Site Public Contact
785-452-7038
mleepers@srhc.com

University of Kansas Health System Saint Francis Campus
Topeka 4280539, Kansas 4273857 66606
Contact:
Site Public Contact
785-295-8000

University of Kansas Hospital-Westwood Cancer Center
Westwood 4281639, Kansas 4273857 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

The James Graham Brown Cancer Center at University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Contact:
Site Public Contact
502-562-3429

UofL Health Medical Center Northeast
Louisville 4299276, Kentucky 6254925 40245
Contact:
Site Public Contact
502-852-2755
ctoinfo@louisville.edu

University of Maryland/Greenebaum Cancer Center
Baltimore 4347778, Maryland 4361885 21201
Contact:
Site Public Contact
800-888-8823

UM Upper Chesapeake Medical Center
Bel Air 4348240, Maryland 4361885 21014
Contact:
Site Public Contact
443-643-3010

Central Maryland Radiation Oncology in Howard County
Columbia 4352053, Maryland 4361885 21044
Contact:
Site Public Contact
443-546-1300

University of Maryland Shore Medical Center at Easton
Easton 4353962, Maryland 4361885 21601
Contact:
Site Public Contact
410-822-1000
Christina.weisenborn@umm.edu

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie 4356188, Maryland 4361885 21061
Contact:
Site Public Contact
410-553-8100

UM Capital Region Medical Center
Largo 4360345, Maryland 4361885 20774
Contact:
Site Public Contact
301-755-4397
Sarah.Larson@umm.edu

Bronson Battle Creek
Battle Creek 4985153, Michigan 5001836 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 5001836 48183
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Michigan Healthcare Professionals Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
941-833-5700
rudi.ross@profoundresearch.io

Henry Ford Macomb Hospital-Clinton Township
Clinton Township 4989133, Michigan 5001836 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Medical Center-Fairlane
Dearborn 4990510, Michigan 5001836 48126
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

OSF Saint Francis Hospital and Medical Group
Escanaba 4992232, Michigan 5001836 49829
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

Michigan Healthcare Professionals Farmington
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Site Public Contact
941-833-5700
rudi.ross@profoundresearch.io

Genesys Hurley Cancer Institute
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-267-1925
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Allegiance Health
Jackson 4997384, Michigan 5001836 49201
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Michigan Healthcare Professionals Macomb
Macomb 5000473, Michigan 5001836 48044
Contact:
Site Public Contact
rudi.ross@profoundresearch.io

Michigan Healthcare Professionals Madison Heights
Madison Heights 5000500, Michigan 5001836 48071
Contact:
Site Public Contact
941-833-5700
rudi.ross@profoundresearch.io

Henry Ford Medical Center-Columbus
Novi 5004062, Michigan 5001836 48377
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Site Public Contact
248-551-7695

MyMichigan Medical Center Saginaw
Saginaw 5007989, Michigan 5001836 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Tawas
Tawas City 5011900, Michigan 5001836 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Beaumont Troy Hospital
Troy 5012639, Michigan 5001836 48085
Contact:
Site Public Contact
248-551-7695

Michigan Healthcare Professionals Troy
Troy 5012639, Michigan 5001836 48098
Contact:
Site Public Contact
rudi.ross@profoundresearch.io

Henry Ford West Bloomfield Hospital
West Bloomfield 7259621, Michigan 5001836 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

University of Michigan Health - West
Wyoming 5015618, Michigan 5001836 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Sanford Joe Lueken Cancer Center
Bemidji 5017822, Minnesota 5037779 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Saint Joseph's Medical Center
Brainerd 5019116, Minnesota 5037779 56401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Deer River Clinic
Deer River 5024099, Minnesota 5037779 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Saint Luke's Hospital of Duluth
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-249-7825
kdean@slhduluth.com

Fairview Southdale Hospital
Edina 5025264, Minnesota 5037779 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Hibbing Clinic
Hibbing 5030005, Minnesota 5037779 55746
Contact:
Site Public Contact
218-786-3308

Abbott-Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Monticello Cancer Center
Monticello 5038045, Minnesota 5037779 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud 5044407, Minnesota 5037779 56303
Contact:
Site Public Contact
877-229-4907
coborncancercenter@centracare.com

Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul 5045360, Minnesota 5037779 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Sandstone
Sandstone 5045908, Minnesota 5037779 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Saint Francis Regional Medical Center
Shakopee 5046997, Minnesota 5037779 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater 5048814, Minnesota 5037779 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Virginia Clinic
Virginia 5051468, Minnesota 5037779 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Ridgeview Medical Center
Waconia 5051640, Minnesota 5037779 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus 4422442, Mississippi 4436296 39705
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Cancer Center-Grenada
Grenada 4428539, Mississippi 4436296 38901
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Union County
New Albany 4438121, Mississippi 4436296 38652
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Oxford
Oxford 4440076, Mississippi 4436296 38655
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven 4446702, Mississippi 4436296 38671
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Parkland Health Center - Farmington
Farmington 4386289, Missouri 4398678 63640
Contact:
Site Public Contact
314-996-5569

University of Kansas Cancer Center - North
Kansas City 4393217, Missouri 4398678 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit 4394870, Missouri 4398678 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City 4400860, Missouri 4398678 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve 4407294, Missouri 4398678 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan 4410669, Missouri 4398678 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills 4410836, Missouri 4398678 63127
Contact:
Site Public Contact
314-996-5569

Billings Clinic Cancer Center
Billings 5640350, Montana 5667009 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman 5641727, Montana 5667009 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Medicine-Bellevue
Bellevue 5063805, Nebraska 5073708 68123
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

CHI Health Good Samaritan
Kearney 5071348, Nebraska 5073708 68847
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Cancer Partners of Nebraska
Lincoln 5072006, Nebraska 5073708 68516
Contact:
Site Public Contact
402-327-7363
research@cancerpartners.com

Nebraska Medicine-Village Pointe
Omaha 5074472, Nebraska 5073708 68118
Contact:
Site Public Contact
402-559-5600

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

OptumCare Cancer Care at Seven Hills
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Las Vegas 5506956, Nevada 5509151 89119
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon 5088597, New Hampshire 5090174 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Memorial Sloan Kettering Basking Ridge
Basking Ridge 5095409, New Jersey 5101760 07920
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Monmouth
Middletown 5101170, New Jersey 5101760 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale 5101361, New Jersey 5101760 07645
Contact:
Site Public Contact
212-639-7592

Northwell Health Imbert Cancer Center
Bay Shore 5108169, New York 5128638 11706
Contact:
Site Public Contact
516-734-8896

Sands Cancer Center
Canandaigua 5111405, New York 5128638 14424
Contact:
Site Public Contact
585-396-6161

Memorial Sloan Kettering Commack
Commack 5113412, New York 5128638 11725
Contact:
Site Public Contact
212-639-7592

Noyes Memorial Hospital/Myers Cancer Center
Dansville 5114492, New York 5128638 14437
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

Northwell Health Cancer Institute at Huntington
Greenlawn 5119377, New York 5128638 11740
Contact:
Site Public Contact
516-734-8896

Memorial Sloan Kettering Westchester
Harrison 5120095, New York 5128638 10604
Contact:
Site Public Contact
212-639-7592

Northwell Health/Center for Advanced Medicine
Lake Success 5123853, New York 5128638 11042
Contact:
Site Public Contact
516-734-8896

Northern Westchester Hospital
Mount Kisco 5127744, New York 5128638 10549
Contact:
Site Public Contact
914-666-1366
AMellor@northwell.edu

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-639-7592

Upstate Cancer Center at Oswego
Oswego 5130081, New York 5128638 13126
Contact:
Site Public Contact
315-464-8230
McDowelE@upstate.edu

Wilmot Cancer Institute Radiation Oncology at Greece
Rochester 5134086, New York 5128638 14606
Contact:
Site Public Contact
585-758-7877

Highland Hospital
Rochester 5134086, New York 5128638 14620
Contact:
Site Public Contact
585-341-8113

Pluta Cancer Center
Rochester 5134086, New York 5128638 14623
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

University of Rochester
Rochester 5134086, New York 5128638 14642
Contact:
Site Public Contact
585-275-5830

Phelps Memorial Hospital Center
Sleepy Hollow 5138371, New York 5128638 10591
Contact:
Site Public Contact
914-366-1600

Staten Island University Hospital
Staten Island 5139568, New York 5128638 10305
Contact:
Site Public Contact
718-226-8888

Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638 11794
Contact:
Site Public Contact
800-862-2215

State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
Site Public Contact
315-464-5476

SUNY Upstate Medical Center-Community Campus
Syracuse 5140405, New York 5128638 13215
Contact:
Site Public Contact
315-464-5476

Montefiore Medical Center-Einstein Campus
The Bronx 5110266, New York 5128638 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
The Bronx 5110266, New York 5128638 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Memorial Sloan Kettering Nassau
Uniondale 5141927, New York 5128638 11553
Contact:
Site Public Contact
212-639-7592

Upstate Cancer Center at Verona
Verona 5142333, New York 5128638 13478
Contact:
Site Public Contact
315-464-8230
McDowelE@upstate.edu

Wilmot Cancer Institute at Webster
Webster 5143495, New York 5128638 14580
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

East Carolina University
Greenville 4469160, North Carolina 4482348 27834
Contact:
Site Public Contact
252-744-1015
eubankss@ecu.edu

Sanford Bismarck Medical Center
Bismarck 5688025, North Dakota 5690763 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Indu and Raj Soin Medical Center
Beavercreek 4506008, Ohio 5165418 45431
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cleveland Clinic Mercy Hospital
Canton 5149222, Ohio 5165418 44708
Contact:
Site Public Contact
888-293-4673

Dayton Physicians LLC-Miami Valley South
Centerville 4508204, Ohio 5165418 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville 4508204, Ohio 5165418 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Riverside Methodist Hospital
Columbus 4509177, Ohio 5165418 43214
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Grant Medical Center
Columbus 4509177, Ohio 5165418 43215
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Doctors Hospital
Columbus 4509177, Ohio 5165418 43228
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Miami Valley Hospital
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-276-8320

Dayton Physician LLC - Englewood
Dayton 4509884, Ohio 5165418 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton 4509884, Ohio 5165418 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Delaware Health Center-Grady Cancer Center
Delaware 5151891, Ohio 5165418 43015
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Grady Memorial Hospital
Delaware 5151891, Ohio 5165418 43015
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Dublin Methodist Hospital
Dublin 5152333, Ohio 5165418 43016
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Atrium Medical Center-Middletown Regional Hospital
Franklin 4512203, Ohio 5165418 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin 4512203, Ohio 5165418 45005
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville 5156493, Ohio 5165418 45331
Contact:
Site Public Contact
937-569-7515

Kettering Medical Center
Kettering 4515843, Ohio 5165418 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

OhioHealth Mansfield Hospital
Mansfield 5161723, Ohio 5165418 44903
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

OhioHealth Marion General Hospital
Marion 5161902, Ohio 5165418 43302
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Dayton Physicians LLC - Troy
Troy 5174358, Ohio 5165418 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Upper Valley Medical Center
Troy 5174358, Ohio 5165418 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City 4544349, Oklahoma 4544379 73120
Contact:
Site Public Contact
405-752-3402

Saint Charles Health System
Bend 5713587, Oregon 5744337 97701
Contact:
Site Public Contact
541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas 5719308, Oregon 5744337 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Legacy Mount Hood Medical Center
Gresham 5729485, Oregon 5744337 97030
Contact:
Site Public Contact
503-413-2150

Providence Newberg Medical Center
Newberg 5742726, Oregon 5744337 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Willamette Falls Medical Center
Oregon City 5744253, Oregon 5744337 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Legacy Good Samaritan Hospital and Medical Center
Portland 5746545, Oregon 5744337 97210
Contact:
Site Public Contact
800-220-4937
cancer@lhs.org

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Legacy Meridian Park Hospital
Tualatin 5757506, Oregon 5744337 97062
Contact:
Site Public Contact
503-413-1742

Penn State Milton S Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

UPMC-Magee Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Site Public Contact
412-647-2811

Women and Infants Hospital
Providence 5224151, Rhode Island 5224323 02905
Contact:
Site Public Contact
401-274-1122

Kent Hospital
Warwick 5225507, Rhode Island 5224323 02886
Contact:
Site Public Contact
401-737-7010

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Lexington Medical Center
West Columbia 4600541, South Carolina 4597040 29169
Contact:
Site Public Contact
803-935-8300
research@lexhealth.org

Sanford Cancer Center Oncology Clinic
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Baptist Memorial Hospital and Cancer Center-Collierville
Collierville 4614748, Tennessee 4662168 38017
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis 4641239, Tennessee 4662168 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

MD Anderson in The Woodlands
Conroe 4682991, Texas 4736286 77384
Contact:
Site Public Contact
866-632-6789
askmdanderson@mdanderson.org

M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson West Houston
Houston 4699066, Texas 4736286 77079
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson League City
League City 4705692, Texas 4736286 77573
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson in Sugar Land
Sugar Land 4734825, Texas 4736286 77478
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Farmington Health Center
Farmington 5774662, Utah 5549030 84025
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

University of Utah Sugarhouse Health Center
Salt Lake City 5780993, Utah 5549030 84106
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Huntsman Cancer Institute/University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington 5234372, Vermont 5242283 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

Dartmouth Cancer Center - North
Saint Johnsbury 5240656, Vermont 5242283 05819
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@hitchcock.org

Bon Secours Memorial Regional Medical Center
Mechanicsville 4772566, Virginia 6254928 23116
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Francis Medical Center
Midlothian 4772943, Virginia 6254928 23114
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Mary's Hospital
Richmond 4781708, Virginia 6254928 23226
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Cancer Institute at Reynolds Crossing
Richmond 4781708, Virginia 6254928 23230
Contact:
Site Public Contact
804-893-8978
Anne_caramella@bshsi.org

Swedish Cancer Institute-Edmonds
Edmonds 5793427, Washington 5815135 98026
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Swedish Cancer Institute-Issaquah
Issaquah 5798487, Washington 5815135 98029
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Kadlec Clinic Hematology and Oncology
Kennewick 5799610, Washington 5815135 99336
Contact:
Site Public Contact
509-783-4637
research@kadlecmed.org

Skagit Regional Health Cancer Care Center
Mount Vernon 5804127, Washington 5815135 98274
Contact:
Site Public Contact
360-814-2182
rcccclinicalresearch@skagitvalleyhospital.org

Swedish Medical Center-Ballard Campus
Seattle 5809844, Washington 5815135 98107
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-First Hill
Seattle 5809844, Washington 5815135 98122
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver 5814616, Washington 5815135 98684
Contact:
Site Public Contact
oncologyresearch@lhs.org

Legacy Salmon Creek Hospital
Vancouver 5814616, Washington 5815135 98686
Contact:
Site Public Contact
503-413-2150

Langlade Hospital and Cancer Center
Antigo 5244010, Wisconsin 5279468 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Duluth Clinic Ashland
Ashland 5244247, Wisconsin 5279468 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Ashland 5244247, Wisconsin 5279468 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay 5254962, Wisconsin 5279468 54301
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

Essentia Health-Hayward Clinic
Hayward 5255882, Wisconsin 5279468 54843
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Froedtert Menomonee Falls Hospital
Menomonee Falls 5262630, Wisconsin 5279468 53051
Contact:
Site Public Contact
262-257-5100

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Site Public Contact
414-805-3666

ProHealth D N Greenwald Center
Mukwonago 5263965, Wisconsin 5279468 53149
Contact:
Site Public Contact
research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond 5264475, Wisconsin 5279468 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Drexel Town Square Health Center
Oak Creek 5265228, Wisconsin 5279468 53154
Contact:
Site Public Contact
414-805-0505

ProHealth Oconomowoc Memorial Hospital
Oconomowoc 5265499, Wisconsin 5279468 53066
Contact:
Site Public Contact
262-928-7878

Aspirus Cancer Care - James Beck Cancer Center
Rhinelander 5268720, Wisconsin 5279468 54501
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan 5272893, Wisconsin 5279468 53081
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Sheboygan Physicians Group
Sheboygan 5272893, Wisconsin 5279468 53081
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Essentia Health-Spooner Clinic
Spooner 5274034, Wisconsin 5279468 54801
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Aspirus Cancer Care - Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54481
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Essentia Health Saint Mary's Hospital - Superior
Superior 5275191, Wisconsin 5279468 54880
Contact:
Site Public Contact
701-364-6272

UW Cancer Center at ProHealth Care
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Aspirus Regional Cancer Center
Wausau 5278120, Wisconsin 5279468 54401
Contact:
Site Public Contact
877-405-6866

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend 5278422, Wisconsin 5279468 53095
Contact:
Site Public Contact
414-805-0505

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Contact:
Site Public Contact
715-422-7718

Cancer Center-Metro Medical Center Bayamon
Bayamón 4562831, Puerto Rico 00959-5060
Contact:
Site Public Contact
787-395-7085

Doctors Cancer Center
Manatí 4566137, Puerto Rico 00674
Contact:
Site Public Contact
787-621-4397

San Juan Community Oncology Group
San Juan 4568127, Puerto Rico 00917
Contact:
Site Public Contact
787-274-3387

Centro Comprensivo de Cancer de UPR
San Juan 4568127, Puerto Rico 00927
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

San Juan City Hospital
San Juan 4568127, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296

More Details

NCT ID
NCT05705401
Status
Recruiting
Sponsor
NRG Oncology

Study Contact

Director, Department of Regulatory Affairs
412-339-5300
langerj@nrgoncology.org

Detailed Description

The landmark trials that established breast conservation therapy (BCT) (breast-conserving surgery followed by adjuvant breast irradiation) as a suitable alternative to mastectomy were conducted in an era that predated biological subtyping of breast cancer and the use of HER2-directed therapies in patients with HER2+ cancers. These trials established adjuvant radiotherapy following breast-conserving surgery as necessary to maximize local control, yet, in the intervening years, overall outcomes have improved significantly owing to widespread adoption of screening mammography, resulting in a substantial reduction in average tumor size at diagnosis, as well as improvements in surgical techniques and, crucial for this proposal, the development of highly active systemic therapies. Before the development of HER2-targeted therapies, patients with HER2-driven localized breast cancer had among the highest rates of local recurrence. However, with improved identification of these patients and the advent of HER2-directed therapies, outcomes have improved significantly, and trials have sought to optimize treatment to reduce the morbidity of both local and systemic treatment. Among the most salient of these examples is the APT trial, a single-arm adjuvant study that enrolled 410 breast cancer patients with HER2+ tumors ≤ 3cm in size and negative axillary nodes, who received adjuvant systemic therapy with weekly paclitaxel and trastuzumab for 12 weeks (TH) followed by 9 months of trastuzumab monotherapy. In addition to demonstrating a very low incidence of distant recurrence, among those on the trial who underwent BCT (lumpectomy and radiation, n = 244), only 2 local recurrence (LR) events have been reported after 7 years of follow-up (7-year LR = 1.2%), representing among the most favorable local outcomes of any breast cancer cohort studied to date. Confirmatory results are forthcoming from the ATEMPT trial, which evaluated the antibody-drug conjugate T-DM1 (ado-trastuzumab emtansine) (n=383) vs the TH regimen from the APT trial (n = 114), thus far showing only 3 LRs in each arm with a median 3-years of follow-up. Importantly, per the current standard of care for HER2+ patients undergoing BCT, all patients presumably received adjuvant breast radiotherapy. The balance of the BCT literature, including a landmark meta-analysis by the Early Breast Cancer Trialists' Collaborative Group, suggests that adjuvant radiotherapy approximately halves the risk of local recurrence following lumpectomy across all analyzable subgroups. While the relative benefit appears constant across subgroups, the absolute benefit of adjuvant radiotherapy varies with the underlying risk. Taking the favorable results of the APT trial (1.2% 7-year LR), if one presumes that omission of radiotherapy yields a doubling or tripling of local recurrence (based on the observed RR of 0.5 - 0.66 for those receiving radiotherapy across the preponderance of historical trials), this population might have manifested a LR rate of 2.4 - 3.6% with the omission of radiotherapy. That is to say, the hypothesis is that administration of RT to APT patients undergoing BCT may have reduced the 7-year absolute risk of LR by only 1.2-2.4%. Through the identification of patients who are at low risk of LR, it may be acceptable for such patients to forego radiation. This hypothesis will be studied by evaluating omission of radiotherapy among patients with pT1N0 disease at breast-conserving surgery who receive adjuvant HER2-directed therapy (trastuzumab/paclitaxel preferred, other options per protocol), or with clinical tumors ≤ 3 cm and clinically negative axillary nodes (cN0) who achieve a pathologic complete response (pCR; ypT0N0) following preoperative (neoadjuvant) administration of HER2-directed therapy (trastuzumab/paclitaxel preferred, other options per protocol). It is expcted that the 5-year LR rate for this population omitting radiotherapy will be 2% or less, and that omission of radiation will not have a measurable impact on regional and distant recurrences or overall survival. The practice of breast radiation oncology has benefited immensely from practice-changing trials that have refined the application of adjuvant radiotherapy since the early surgical studies determined whole breast radiotherapy to be necessary following lumpectomy. There are now several favorable breast cancer subtypes in which patients routinely forego radiotherapy after trials demonstrating modest benefits in terms of local recurrence and no impact on distant recurrence or survival, such as among small, low grade luminal cancers in older women and "good-risk" DCIS. Therefore, this will study the omission of radiotherapy among a population of HER2+ breast cancer patients who are now appreciated to also have favorable risk, so as to similarly weigh the attendant inconveniences, cost and morbidity of radiotherapy in light of an established absolute benefit, which may prove to be modest.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.