ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

Purpose

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Early Stage Breast Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible) - Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible - HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer - Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR - If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts (including the requirement that at least one biopsied site on each side must have been HER2+) - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively - Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.) - Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped > 12 months prior to registration on this protocol - No use of investigational anti-cancer agents at time of registration - Patient must register within 14 weeks of final surgery - Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows: - Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed - Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon - Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible - Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion - Targeting of the regional nodal basins will be at treating investigator discretion - Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice - Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility - No stage IV (metastatic) breast cancer - 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 - No history of any prior (ipsilateral [ipsi-] or contralateral) invasive breast cancer. Prior DCIS is allowed - No evidence of recurrent disease following preoperative therapy and surgery - Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial. - Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF < 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA) - No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab - No contraindication to receipt of further HER2-directed therapy - No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.

Exclusion Criteria

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm 1 (12-month adjuvant therapy)
Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.
  • Biological: Trastuzumab (Herceptin)
    Given IV or SC
  • Biological: Pertuzumab
    Given IV or SC
  • Procedure: Echocardiography
    Undergo ECHO
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
  • Procedure: Mammography
    Undergo mammography
  • Procedure: Ultrasound
    Undergo ultrasound
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
  • Procedure: Biospecimen Collection
    Undergo blood and tissue sample collection
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm 2 (6-month adjuvant therapy)
Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.
  • Biological: Trastuzumab (Herceptin)
    Given IV or SC
  • Biological: Pertuzumab
    Given IV or SC
  • Procedure: Echocardiography
    Undergo ECHO
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
  • Procedure: Mammography
    Undergo mammography
  • Procedure: Ultrasound
    Undergo ultrasound
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
  • Procedure: Biospecimen Collection
    Undergo blood and tissue sample collection
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Mercy Cancer Center - Carmichael
Carmichael, California 95608
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
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916-556-3301
OncologyResearch@DignityHealth.org

Enloe Medical Center
Chico, California 95926
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530-332-4700

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

Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
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720-874-1881
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Kaiser Permanente-Fremont
Fremont, California 94538
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877-642-4691
Kpoct@kp.org

Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
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833-574-2273

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

UC San Diego Moores Cancer Center
La Jolla, California 92093
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858-822-5354
cancercto@ucsd.edu

Fremont - Rideout Cancer Center
Marysville, California 95901
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530-749-4400

Kaiser Permanente- Modesto MOB II
Modesto, California 95356
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877-642-4691

Kaiser Permanente-Modesto
Modesto, California 95356
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877-642-4691
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Kaiser Permanente-Oakland
Oakland, California 94611
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877-642-4691
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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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Mercy Cancer Center - Rocklin
Rocklin, California 95765
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720-874-1881
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Kaiser Permanente-Roseville
Roseville, California 95661
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Kaiser Permanente Downtown Commons
Sacramento, California 95814
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Mercy Cancer Center - Sacramento
Sacramento, California 95816
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720-874-1881
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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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UC San Diego Medical Center - Hillcrest
San Diego, California 92103
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rhabbaba@health.ucsd.edu

Kaiser Permanente-San Francisco
San Francisco, California 94115
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
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Kaiser Permanente San Leandro
San Leandro, California 94577
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Kaiser San Rafael-Gallinas
San Rafael, California 94903
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
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Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
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Kaiser Permanente-South San Francisco
South San Francisco, California 94080
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Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
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530-582-6450

Kaiser Permanente-Vallejo
Vallejo, California 94589
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877-642-4691
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Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
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Woodland Memorial Hospital
Woodland, California 95695
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720-874-1881
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UCI Health - Yorba Linda
Yorba Linda, California 92886
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877-827-8839
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Shaw Cancer Center
Edwards, Colorado 81632
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970-569-7429

Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
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203-785-5702
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
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Yale University
New Haven, Connecticut 06520
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203-785-5702
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
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203-785-5702
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
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Beebe South Coastal Health Campus
Millville, Delaware 19967
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302-291-6730
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Helen F Graham Cancer Center
Newark, Delaware 19713
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302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
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302-623-4450
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Beebe Health Campus
Rehoboth Beach, Delaware 19971
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302-291-6730
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
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202-444-2223

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
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202-877-8839

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

Jupiter Medical Center
Jupiter, Florida 33458
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561-263-5791
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The Watson Clinic
Lakeland, Florida 33805
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863-680-7780

Sacred Heart Hospital
Pensacola, Florida 32504
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850-416-4611
eebrou@ascension.org

South Florida Baptist Hospital
Plant City, Florida 33563
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813-707-2155
Claudia.Quinones@baycare.org

Saint Anthony's Hospital Cancer Care Center
St. Petersburg, Florida 33705
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Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
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813-357-0849
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Winter Haven Hospital
Winter Haven, Florida 33881
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803-293-1121
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Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
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808-432-5195
shelley.a.clark@kp.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
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208-381-2774
eslinget@slhs.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
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406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
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208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
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208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
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406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
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208-381-2774
eslinget@slhs.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
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406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
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406-969-6060
mccinfo@mtcancer.org

Rush-Copley Medical Center
Aurora, Illinois 60504
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630-978-6212
RCMC_Cancer_Research@rush.edu

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
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309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
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309-243-3605
andersonj@illinoiscancercare.com

SIH Cancer Institute
Carterville, Illinois 62918
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618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage, Illinois 62321
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309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
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217-876-4762
morganthaler.jodi@mhsil.com

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

University of Illinois
Chicago, Illinois 60612
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312-355-3046

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

Carle at The Riverfront
Danville, Illinois 61832
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800-446-5532
Research@Carle.com

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

Illinois CancerCare-Dixon
Dixon, Illinois 61021
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815-285-7800

Carle Physician Group-Effingham
Effingham, Illinois 62401
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800-446-5532
Research@carle.com

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

Illinois CancerCare-Eureka
Eureka, Illinois 61530
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309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
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309-243-3605
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
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630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
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312-695-1102

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

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

UChicago Medicine AdventHealth Cancer Institute Hinsdale
Hinsdale, Illinois 60521
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cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
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309-243-3605
andersonj@illinoiscancercare.com

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

Illinois CancerCare-Macomb
Macomb, Illinois 61455
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309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
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800-446-5532
Research@carle.com

Trinity Medical Center
Moline, Illinois 61265
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309-779-2000

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

Carle BroMenn Medical Center
Normal, Illinois 61761
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800-446-5532
Research@Carle.com

Carle Cancer Institute Normal
Normal, Illinois 61761
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800-446-5532
Research@Carle.com

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

Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
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nctnprogram_rhlccc@northwestern.edu

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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773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
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309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
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309-243-3605
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Illinois CancerCare-Peoria
Peoria, Illinois 61615
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309-243-3605
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Illinois CancerCare-Peru
Peru, Illinois 61354
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309-243-3605
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Illinois CancerCare-Princeton
Princeton, Illinois 61356
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309-243-3605
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Memorial Hospital East
Shiloh, Illinois 62269
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314-747-9912
dschwab@wustl.edu

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

Springfield Clinic
Springfield, Illinois 62702
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800-444-7541

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

Carle Cancer Center
Urbana, Illinois 61801
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800-446-5532
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
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630-352-5360
Donald.Smith3@nm.org

Illinois CancerCare - Washington
Washington, Illinois 61571
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309-243-3605
andersonj@illinoiscancercare.com

Rush-Copley Healthcare Center
Yorkville, Illinois 60560
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630-978-6212
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IU Health West Hospital
Avon, Indiana 46123
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317-278-5632
iutrials@iu.edu

IU Health North Hospital
Carmel, Indiana 46032
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317-278-5632
iutrials@iu.edu

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

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
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317-278-5632
iutrials@iu.edu

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

McFarland Clinic - Ames
Ames, Iowa 50010
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515-239-4734
ksoder@mcfarlandclinic.com

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

McFarland Clinic - Boone
Boone, Iowa 50036
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Site Public Contact
515-956-4132

Saint Anthony Regional Hospital
Carroll, Iowa 51401
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Site Public Contact
515-689-7658
sbenson@iora.org

Mercy Hospital
Cedar Rapids, Iowa 52403
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Site Public Contact
319-365-4673

Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
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319-363-2690

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

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

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

Broadlawns Medical Center
Des Moines, Iowa 50314
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515-282-2200

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

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

McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
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Site Public Contact
515-956-4132

UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-282-2921
trials@missioncancer.com

McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132

UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa 50219
Contact:
Site Public Contact
515-282-2921
trials@missioncancer.com

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

The Iowa Clinic PC
West Des Moines, Iowa 50266
Contact:
Site Public Contact
515-875-9815

Cancer Center of Kansas - Chanute
Chanute, Kansas 66720
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Dodge City
Dodge City, Kansas 67801
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - El Dorado
El Dorado, Kansas 67042
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas-Independence
Independence, Kansas 67301
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas-Kingman
Kingman, Kansas 67068
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Site Public Contact
785-505-2800
Stephanie.Norris@LMH.ORG

Cancer Center of Kansas-Liberal
Liberal, Kansas 67905
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Newton
Newton, Kansas 67114
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

Cancer Center of Kansas - Parsons
Parsons, Kansas 67357
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Pratt
Pratt, Kansas 67124
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Salina
Salina, Kansas 67401
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

Cancer Center of Kansas - Wellington
Wellington, Kansas 67152
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas 67208
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Winfield
Winfield, Kansas 67156
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine 04011
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

Penobscot Bay Medical Center
Rockport, Maine 04856
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600

MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland 21001
Contact:
Site Public Contact
443-643-1029
nfadrwoski@umm.edu

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

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

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland 21237
Contact:
Site Public Contact
443-777-7364

MedStar Good Samaritan Hospital
Baltimore, Maryland 21239
Contact:
Site Public Contact
410-261-8151
Barbara.rector@medstar.net

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

MedStar Health Bel Air Medical Campus
Bel Air, Maryland 21015
Contact:
Site Public Contact
David.j.perry2@medstar.net

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

MedStar Southern Maryland Hospital Center
Clinton, Maryland 20735
Contact:
Site Public Contact
301-877-4673

UPMC Western Maryland
Cumberland, Maryland 21502
Contact:
Site Public Contact
240-964-1400

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

MedStar Montgomery Medical Center
Olney, Maryland 20832
Contact:
Site Public Contact
855-546-1944

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
CancerAnswerLine@med.umich.edu

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

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

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

Cancer Hematology Centers - Flint
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
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

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

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Hope Cancer Center
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

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

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

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

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.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

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

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

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

Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320

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

Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320

Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri 63011
Contact:
Site Public Contact
888-446-3729

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

Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

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

University Health Truman Medical Center
Kansas City, Missouri 64108
Contact:
Site Public Contact
816-404-4375

University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671

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

Lake Regional Hospital
Osage Beach, Missouri 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

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

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
St Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

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

Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

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

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

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

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

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Logan Health Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
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

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

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

Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey 08002
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Site Public Contact
551-996-2897

Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

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

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

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Novant Health Presbyterian Medical Center
Charlotte, North Carolina 28204
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
Contact:
Site Public Contact
828-696-4716
pardeecancerresearch@unchealth.unc.edu

Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina 28078
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina 27284
Contact:
Site Public Contact
336-718-8335
asmarrs@novanthealth.org

Novant Health Cancer Institute - Matthews
Matthews, North Carolina 28105
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina 28117
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina 27030
Contact:
Site Public Contact
336-718-8335
asmarrs@novanthealth.org

FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
Contact:
Site Public Contact
910-715-3500
jcwilliams@firsthealth.org

Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina 27360
Contact:
Site Public Contact
336-718-8335
pjordan@novanthealth.org

Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
Contact:
Site Public Contact
336-718-8335
pjordan@novanthealth.org

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

Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.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

Aultman Health Foundation
Canton, Ohio 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

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

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

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

Miami Valley Hospital
Dayton, Ohio 45409
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

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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

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

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

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

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

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

Providence Hood River Memorial Hospital
Hood River, Oregon 97031
Contact:
Site Public Contact
503-215-1979
canrsrchstudies@provdience.org

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

UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania 16001
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania 17201
Contact:
Site Public Contact
717-217-6020

UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania 16066
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

Saint Vincent Hospital
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000

UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

IRMC Cancer Center
Indiana, Pennsylvania 15701
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Contact:
Site Public Contact
814-534-4724

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania 15132
Contact:
Site Public Contact
412-647-8073

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Forbes Hospital
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746

UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania 15642
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania 16105
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412-389-5208
haneydl@upmc.edu

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-600-9151
ONCTrialNow@jefferson.edu

Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
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215-600-9151
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Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
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877-284-2000

UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
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412-647-2811

UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
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412-784-4900

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
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412-367-6454

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
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412-502-3920

UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
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814-676-7900

UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania 15401
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773-702-9171
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UPMC Cancer Center-Washington
Washington, Pennsylvania 15301
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UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania 15122
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412-653-8100

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
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Dawnmarie.DeFazio@ahn.org

Divine Providence Hospital
Williamsport, Pennsylvania 17754
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773-702-9171
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Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
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215-600-9151
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Cancer Care Associates of York
York, Pennsylvania 17403
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717-741-9229

WellSpan Health-York Cancer Center
York, Pennsylvania 17403
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877-441-7957

Rhode Island Hospital
Providence, Rhode Island 02903
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401-444-1488

Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
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203-785-5702
canceranswers@yale.edu

Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
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864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
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864-522-4317
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Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
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Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
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864-522-4317
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Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
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864-522-4317
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Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
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864-522-4317
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Lexington Medical Center
West Columbia, South Carolina 29169
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803-935-8300
research@lexhealth.org

Rapid City Regional Hospital
Rapid City, South Dakota 57701
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605-755-2370
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
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605-312-3320
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
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605-312-3320
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Houston Methodist San Jacinto Hospital
Baytown, Texas 77521
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MD Anderson in The Woodlands
Conroe, Texas 77384
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866-632-6789
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Houston Methodist Cypress Hospital
Cypress, Texas 77429
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346-356-1413
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Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
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713-566-5000

Houston Methodist Hospital
Houston, Texas 77030
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M D Anderson Cancer Center
Houston, Texas 77030
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Methodist Willowbrook Hospital
Houston, Texas 77070
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MD Anderson West Houston
Houston, Texas 77079
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Houston Methodist West Hospital
Houston, Texas 77094
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MD Anderson League City
League City, Texas 77573
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Houston Methodist Saint John Hospital
Nassau Bay, Texas 77058
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MD Anderson in Sugar Land
Sugar Land, Texas 77478
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Houston Methodist Sugar Land Hospital
Sugar Land, Texas 77479
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Houston Methodist The Woodlands Hospital
The Woodlands, Texas 77385
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713-790-2700
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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888-424-2100
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Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
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800-639-6918
cancer.research.nurse@hitchcock.org

Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia 24501
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434-200-1495
Kevin.Patel@centrahealth.com

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

Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
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804-893-8978
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Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
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804-893-8978
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Virginia Cancer Institute
Richmond, Virginia 23229
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804-287-3000
smoore@vacancer.com

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
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ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
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804-628-6430
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VCU Community Memorial Health Center
South Hill, Virginia 23970
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nemer.elmouallem@vcuhealth.org

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
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206-215-2343
PCRC-NCORP@Swedish.org

Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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206-215-2343
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Swedish Medical Center-First Hill
Seattle, Washington 98122
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206-215-2343
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Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
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oncologyresearch@lhs.org

Legacy Salmon Creek Hospital
Vancouver, Washington 98686
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503-413-2150

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
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304-399-6566
Christina.Cole@chhi.org

West Virginia University Healthcare
Morgantown, West Virginia 26506
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304-293-7374
cancertrialsinfo@hsc.wvu.edu

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

Duluth Clinic Ashland
Ashland, Wisconsin 54806
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218-786-3308
CancerTrials@EssentiaHealth.org

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

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
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920-433-8889
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
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800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
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800-622-8922
clinicaltrials@cancer.wisc.edu

Aspirus Medford Hospital
Medford, Wisconsin 54451
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715-847-2353
Beth.Knetter@aspirus.org

Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
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262-257-5100

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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research.institute@phci.org

Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
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414-805-0505

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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262-928-7878

Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
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920-433-8889
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Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
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715-847-2353
Beth.Knetter@aspirus.org

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

Sheboygan Physicians Group
Sheboygan, Wisconsin 53081
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920-433-8889
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Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
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715-847-2353
Beth.Knetter@aspirus.org

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

ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
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262-928-7632

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

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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877-405-6866

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
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414-805-0505

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
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715-422-7718

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

Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
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888-823-5923
ctsucontact@westat.com

PROncology
San Juan, Puerto Rico 00927
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787-919-7919
info@PRoncology.com

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

More Details

NCT ID
NCT06876714
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Jack Beranek
773-702-9171
breastprotocols@alliancenctn.org

Detailed Description

The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate whether 6 months of combined neoadjuvant (neo)/adjuvant HER2 blockade results in a non-inferior recurrence-free survival (RFS) compared to 12 months of combined neo/adjuvant HER2 blockade, in patients with early stage HER2+ breast cancer who achieve pCR after neoadjuvant chemotherapy with HER2 blockade. II. To compare the Functional Assessment of Cancer Therapy-Breast (FACT-B) total score at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) SECONDARY OBJECTIVES: I. Secondary objectives are to evaluate whether 6 months compared to 12 months results in differences for the following: Ia. Grade 3 or higher adverse event (AE) rates; Ib. Overall survival (OS); Ic. Locoregional recurrence (LRR, both isolated LRR as first events, and LRR events simultaneous with distant metastasis [DM]) incidence; Id. RFS for key subgroups: baseline stage, hormone receptor (HR) status, neoadjuvant chemotherapy backbone, and dual versus single HER2 blockade in the adjuvant setting; Ie. Time to central nervous system (CNS) recurrence (both isolated CNS recurrence as first events, and CNS recurrence events simultaneous with distant metastasis and/or LRR). II. To compare the FACT-B total score at 18 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) III. To compare side effect bother as measured by the Functional Assessment of Cancer Therapy General Population 5 (FACT GP5) item at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) IV. To compare specific patient-reported symptomatic adverse events (i.e. diarrhea, constipation, fatigue, and rash) as measured by the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) QUALITY OF LIFE EXPLORATORY OBJECTIVES: I. To examine the different FACT-B subscales at all other evaluable time points. II. To examine heterogeneity of treatment effects within subgroups defined by subcutaneous versus intravenous treatment delivery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive trastuzumab intravenously (IV) or subcutaneously (SC) on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) or multigated acquisition (MUGA) as well as mammography, ultrasound, or magnetic resonance imaging (MRI) throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial. ARM 2: Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial. After completion of study treatment, patients are followed up every 6 months for 5 years after registration or until recurrence and then annually for a total of 10 years after registration.