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 Genders
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, Arizona 85004
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Banner University Medical Center - Tucson
Tucson, Arizona 85719
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UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
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UACC-IIT@uacc.arizona.edu

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
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877-642-4691
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Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
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PCR Oncology
Arroyo Grande, California 93420
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702-384-0013
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Sutter Auburn Faith Hospital
Auburn, California 95602
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clinicalresearch@sutterhealth.org

Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
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Tower Cancer Research Foundation
Beverly Hills, California 90211
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towercancerresearch@toweroncology.com

Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California 95682
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City of Hope Comprehensive Cancer Center
Duarte, California 91010
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800-826-4673
becomingapatient@coh.org

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

Kaiser Permanente-Fremont
Fremont, California 94538
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877-642-4691
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Palo Alto Medical Foundation-Fremont
Fremont, California 94538
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clinicalresearch@sutterhealth.org

Fresno Cancer Center
Fresno, California 93720
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877-642-4691
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Kaiser Permanente-Fresno
Fresno, California 93720
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877-642-4691
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
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877-827-8839
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City of Hope at Irvine Lennar
Irvine, California 92618
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877-467-3411

City of Hope Antelope Valley
Lancaster, California 93534
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Los Angeles General Medical Center
Los Angeles, California 90033
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323-865-0451
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USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
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Cedars Sinai Medical Center
Los Angeles, California 90048
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310-423-8965

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

Kaiser Permanente-Modesto
Modesto, California 95356
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877-642-4691
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Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
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Kaiser Permanente Oakland-Broadway
Oakland, California 94611
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Kaiser Permanente-Oakland
Oakland, California 94611
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
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877-827-8839
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Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
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Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
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650-498-7061
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Pomona Valley Hospital Medical Center
Pomona, California 91767
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909-865-9555

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

Kaiser Permanente-Richmond
Richmond, California 94801
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Rohnert Park Cancer Center
Rohnert Park, California 94928
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Kaiser Permanente-Roseville
Roseville, California 95661
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Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
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Sutter Roseville Medical Center
Roseville, California 95661
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The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
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Kaiser Permanente Downtown Commons
Sacramento, California 95814
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Sutter Medical Center Sacramento
Sacramento, California 95816
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University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
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916-734-3089

Kaiser Permanente-South Sacramento
Sacramento, California 95823
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877-642-4691
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South Sacramento Cancer Center
Sacramento, California 95823
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California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
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Kaiser Permanente-San Francisco
San Francisco, California 94115
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877-642-4691
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
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Stanford Cancer Center South Bay
San Jose, California 95124
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650-498-7061
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Kaiser Permanente San Leandro
San Leandro, California 94577
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Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
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Kaiser San Rafael-Gallinas
San Rafael, California 94903
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877-642-4691
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Ridley-Tree Cancer Center
Santa Barbara, California 93105
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
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Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
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Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
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Sutter Pacific Medical Foundation
Santa Rosa, California 95403
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415-209-2683
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City of Hope South Pasadena
South Pasadena, California 91030
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800-826-4673
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Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
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Kaiser Permanente-South San Francisco
South San Francisco, California 94080
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Kaiser Permanente-Stockton
Stockton, California 95210
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Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
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Cedars-Sinai Cancer - Tarzana
Tarzana, California 91356
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818-981-3818

City of Hope South Bay
Torrance, California 90503
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Torrance Memorial Physician Network - Cancer Care
Torrance, California 90505
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310-750-3300
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City of Hope Upland
Upland, California 91786
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Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
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Kaiser Permanente-Vallejo
Vallejo, California 94589
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Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
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UCHealth University of Colorado Hospital
Aurora, Colorado 80045
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720-848-0650

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
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720-874-1881
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Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
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720-874-1881
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UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
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719-365-2406

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

Saint Francis Cancer Center
Colorado Springs, Colorado 80923
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720-874-1881
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Poudre Valley Hospital
Fort Collins, Colorado 80524
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970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
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412-339-5294
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UCHealth Greeley Hospital
Greeley, Colorado 80631
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412-339-5294
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UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
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Medical Center of the Rockies
Loveland, Colorado 80538
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970-203-7083

John Fitzgerald Kennedy Medical Center
Atlantis, Florida 33462
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561-964-2662

Morton Plant Hospital
Clearwater, Florida 33756
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855-314-8646

Lee Memorial Health System
Fort Myers, Florida 33901
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877-680-0008

Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida 33905
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412-339-5294
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Sarasota Memorial Hospital-Venice
N. Venice, Florida 34275
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941-261-9000

GenesisCare USA - Plantation
Plantation, Florida 33324
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941-833-5700
Rudi.Ross@usa.genesiscare.com

Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232
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412-339-5294
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Intercoastal Medical Group - Cattleridge II
Sarasota, Florida 34232
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941-200-1125

Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
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941-957-1000

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

First Physicians Group-Sarasota
Sarasota, Florida 34239
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941-917-8383

Sarasota Memorial Hospital
Sarasota, Florida 34239
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941-917-2225

Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida 34243
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941-917-6519

Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
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800-679-0775
ClinicalTrials@moffitt.org

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

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

Florida Cancer Specialists - Venice Pinebrook
Venice, Florida 34275
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239-274-9930
ClinicalTrials@FLCancer.com

Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
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800-679-0775
ClinicalTrials@moffitt.org

Grady Health System
Atlanta, Georgia 30303
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404-778-1868

Emory Proton Therapy Center
Atlanta, Georgia 30308
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404-251-2854
allyson.anderson@emory.edu

Emory University Hospital Midtown
Atlanta, Georgia 30308
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888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
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404-851-7115

Emory Decatur Hospital
Decatur, Georgia 30033
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440-778-1868
clinicaltrialsoncology@dekalbmedical.org

Emory Johns Creek Hospital
Johns Creek, Georgia 30097
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404-778-5714
m.lisa.hwang@emory.edu

CTCA at Southeastern Regional Medical Center
Newnan, Georgia 30265
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770-400-6629

South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia 31602
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229-259-4628
maryann.heddon@sgmc.org

Hawaii Cancer Care - Westridge
'Aiea, Hawaii 96701
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808-539-2273
info@hawaiicancercare.com

Pali Momi Medical Center
'Aiea, Hawaii 96701
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808-486-6000

Queen's Cancer Center - Pearlridge
'Aiea, Hawaii 96701
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808-487-7447

The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii 96701
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808-678-9000

The Queen's Medical Center - West Oahu
'Ewa Beach, Hawaii 96706
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rohta@queens.org

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
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808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
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808-532-0315

Queen's Medical Center
Honolulu, Hawaii 96813
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808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
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808-522-4333

University of Hawaii Cancer Center
Honolulu, Hawaii 96813
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808-586-2979

Kuakini Medical Center
Honolulu, Hawaii 96817
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808-547-9816

Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
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808-531-8521

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
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808-983-6090

Castle Medical Center
Kailua, Hawaii 96734
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412-339-5294
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Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766
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808-535-7960

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
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208-381-2774
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Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
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208-381-2774
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Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
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208-381-2774
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Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
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208-381-2774
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Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
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208-381-2774
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Centralia Oncology Clinic
Centralia, Illinois 62801
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217-876-4762
morganthaler.jodi@mhsil.com

Saint Mary's Hospital
Centralia, Illinois 62801
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412-339-5294
Roster@nrgoncology.org

Northwestern University
Chicago, Illinois 60611
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312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
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312-864-5204

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
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773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
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217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
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217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
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630-352-5360
Donald.Smith3@nm.org

Crossroads Cancer Center
Effingham, Illinois 62401
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217-876-4762
morganthaler.jodi@mhsil.com

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

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
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630-352-5360
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Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
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312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Contact:
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312-695-1102

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

Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Contact:
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cancertrials@northwestern.edu

Loyola University Medical Center
Maywood, Illinois 60153
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708-226-4357

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

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
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773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
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217-876-4762
morganthaler.jodi@mhsil.com

HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
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217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Orland Park
Orland Park, Illinois 60462
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nctnprogram_rhlccc@northwestern.edu

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

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
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217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
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800-444-7541

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

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
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630-352-5360
Donald.Smith3@nm.org

Midwestern Regional Medical Center
Zion, Illinois 60099
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844-793-0745

UChicago Medicine Northwest Indiana
Crown Point, Indiana 46307
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855-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Goshen Center for Cancer Care
Goshen, Indiana 46526
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574-364-2973
cccois@goshenhealth.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Greater Baltimore Medical Center
Baltimore, Maryland 21204
Contact:
Site Public Contact
443-849-3706

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 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, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

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

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

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

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

Swedish Medical Center-First Hill
Seattle, Washington 98122
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

San Juan City Hospital
San Juan, 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.