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 5334336, California 5332921 95608
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy San Juan Medical Center
Carmichael 5334336, California 5332921 95608
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Enloe Medical Center
Chico 5336269, California 5332921 95926
Contact:
Site Public Contact
530-332-4700

Kaiser Permanente Dublin
Dublin 5344157, California 5332921 94568
Contact:
Site Public Contact
877-642-4691

Mercy Cancer Center - Elk Grove
Elk Grove 5346111, California 5332921 95758
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

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

Kaiser Permanente Fresno Orchard Plaza
Fresno 5350937, California 5332921 93720
Contact:
Site Public Contact
833-574-2273

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

Fremont - Rideout Cancer Center
Marysville 5370984, California 5332921 95901
Contact:
Site Public Contact
530-749-4400

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

Kaiser Permanente-Oakland
Oakland 5378538, California 5332921 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

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

Mercy Cancer Center - Rocklin
Rocklin 5388319, California 5332921 95765
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

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

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

Mercy Cancer Center - Sacramento
Sacramento 5389489, California 5332921 95816
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

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

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

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

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

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

Kaiser San Rafael-Gallinas
San Rafael 5392567, California 5332921 94903
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877-642-4691
Kpoct@kp.org

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

Kaiser Permanente-Santa Rosa
Santa Rosa 5393287, California 5332921 95403
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877-642-4691
Kpoct@kp.org

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

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee 5403676, California 5332921 96161
Contact:
Site Public Contact
530-582-6450

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

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

Woodland Memorial Hospital
Woodland 5410430, California 5332921 95695
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Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UCI Health - Yorba Linda
Yorba Linda 5410902, California 5332921 92886
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Shaw Cancer Center
Edwards 5420885, Colorado 5417618 81632
Contact:
Site Public Contact
970-569-7429

Smilow Cancer Hospital-Derby Care Center
Derby 4832745, Connecticut 4831725 06418
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Fairfield
Fairfield 4834157, Connecticut 4831725 06824
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury 4835003, Connecticut 4831725 06033
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Greenwich
Greenwich 4835395, Connecticut 4831725 06830
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Guilford
Guilford 4835512, Connecticut 4831725 06437
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Saint Francis
Hartford 4835797, Connecticut 4831725 06105
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven 4839366, Connecticut 4831725 06520
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203-785-5702
canceranswers@yale.edu

Yale-New Haven Hospital North Haven Medical Center
North Haven 4839704, Connecticut 4831725 06473
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Long Ridge
Stamford 4843564, Connecticut 4831725 06902
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington 4844309, Connecticut 4831725 06790
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull 4844459, Connecticut 4831725 06611
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203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Waterbury Care Center
Waterbury 4845193, Connecticut 4831725 06708
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford 8480031, Connecticut 4831725 06385
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Site Public Contact
203-785-5702
canceranswers@yale.edu

Beebe South Coastal Health Campus
Millville 4143696, Delaware 4142224 19967
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Helen F Graham Cancer Center
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark 4143861, Delaware 4142224 19713
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Site Public Contact
302-623-4450
lbarone@christianacare.org

Beebe Health Campus
Rehoboth Beach 4144284, Delaware 4142224 19971
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Site Public Contact
302-291-6730
research@beebehealthcare.org

MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Site Public Contact
202-444-2223

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
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202-877-8839

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

Jupiter Medical Center
Jupiter 4160610, Florida 4155751 33458
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Site Public Contact
561-263-5791
clinicaltrials@jupitermed.com

Sacred Heart Hospital
Pensacola 4168228, Florida 4155751 32504
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Site Public Contact
850-416-4611
eebrou@ascension.org

South Florida Baptist Hospital
Plant City 4168773, Florida 4155751 33563
Contact:
Site Public Contact
813-707-2155
Claudia.Quinones@baycare.org

Saint Anthony's Hospital Cancer Care Center
St. Petersburg 4171563, Florida 4155751 33705
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Site Public Contact
Research.CTO@baycare.org

Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751 33607
Contact:
Site Public Contact
813-357-0849
jennifer.manns@baycare.org

Winter Haven Hospital
Winter Haven 4178552, Florida 4155751 33881
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Site Public Contact
803-293-1121
Research.CTO@baycare.org

Kaiser Permanente Moanalua Medical Center
Honolulu 5856195, Hawaii 5855797 96819
Contact:
Site Public Contact
808-432-5195
shelley.a.clark@kp.org

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

Kootenai Health - Coeur d'Alene
Coeur d'Alene 5589173, Idaho 5596512 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

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

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

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

Kootenai Clinic Cancer Services - Post Falls
Post Falls 5604353, Idaho 5596512 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint
Sandpoint 5606401, Idaho 5596512 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Illinois CancerCare-Bloomington
Bloomington 4885164, Illinois 4896861 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton 4831990, Illinois 4896861 61520
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Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

SIH Cancer Institute
Carterville 4235311, Illinois 4896861 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage 4886716, Illinois 4896861 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

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

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

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

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

Illinois CancerCare-Dixon
Dixon 4889959, Illinois 4896861 61021
Contact:
Site Public Contact
815-285-7800

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

Illinois CancerCare-Eureka
Eureka 4891310, Illinois 4896861 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg 4893392, Illinois 4896861 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

UChicago Medicine AdventHealth Cancer Institute Hinsdale
Hinsdale 4896012, Illinois 4896861 60521
Contact:
Site Public Contact
cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Kewanee Clinic
Kewanee 4898433, Illinois 4896861 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb 4900817, Illinois 4896861 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

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

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

Illinois CancerCare-Ottawa Clinic
Ottawa 4905006, Illinois 4896861 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin 4905599, Illinois 4896861 61554
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Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria 4905687, Illinois 4896861 61615
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Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru 4905770, Illinois 4896861 61354
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309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton 4906818, Illinois 4896861 61356
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Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

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

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

Illinois CancerCare - Washington
Washington 4915545, Illinois 4896861 61571
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Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

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

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

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

McFarland Clinic - Boone
Boone 4849051, Iowa 4862182 50036
Contact:
Site Public Contact
515-956-4132

Saint Anthony Regional Hospital
Carroll 4850478, Iowa 4862182 51401
Contact:
Site Public Contact
515-689-7658
sbenson@iora.org

Mercy Hospital
Cedar Rapids 4850751, Iowa 4862182 52403
Contact:
Site Public Contact
319-365-4673

Oncology Associates at Mercy Medical Center
Cedar Rapids 4850751, Iowa 4862182 52403
Contact:
Site Public Contact
319-363-2690

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

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

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

Broadlawns Medical Center
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-282-2200

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

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

McFarland Clinic - Trinity Cancer Center
Fort Dodge 4857486, Iowa 4862182 50501
Contact:
Site Public Contact
515-956-4132

UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge 4857486, Iowa 4862182 50501
Contact:
Site Public Contact
515-282-2921
trials@missioncancer.com

McFarland Clinic - Jefferson
Jefferson 4862482, Iowa 4862182 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Marshalltown
Marshalltown 4866371, Iowa 4862182 50158
Contact:
Site Public Contact
515-956-4132

UI Healthcare Mission Cancer and Blood - Pella
Pella 4870915, Iowa 4862182 50219
Contact:
Site Public Contact
515-282-2921
trials@missioncancer.com

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

The Iowa Clinic PC
West Des Moines 4881346, Iowa 4862182 50266
Contact:
Site Public Contact
515-875-9815

Cancer Center of Kansas - Chanute
Chanute 4269392, Kansas 4273857 66720
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Dodge City
Dodge City 5445298, Kansas 4273857 67801
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - El Dorado
El Dorado 4270863, Kansas 4273857 67042
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas-Independence
Independence 4273359, Kansas 4273857 67301
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas-Kingman
Kingman 4273978, Kansas 4273857 67068
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas-Liberal
Liberal 5445820, Kansas 4273857 67905
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Newton
Newton 4276248, Kansas 4273857 67114
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

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

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

Cancer Center of Kansas - Parsons
Parsons 4277011, Kansas 4273857 67357
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Pratt
Pratt 4277752, Kansas 4273857 67124
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Salina
Salina 4278890, Kansas 4273857 67401
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

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

Cancer Center of Kansas - Wellington
Wellington 4281386, Kansas 4273857 67152
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita 4281730, Kansas 4273857 67208
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Ascension Via Christi Hospitals Wichita
Wichita 4281730, Kansas 4273857 67214
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Wichita
Wichita 4281730, Kansas 4273857 67214
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

Cancer Center of Kansas - Winfield
Winfield 4281897, Kansas 4273857 67156
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

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

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

University Medical Center New Orleans
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Ochsner Medical Center Jefferson
New Orleans 4335045, Louisiana 4331987 70121
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Lafayette Family Cancer Center-EMMC
Brewer 4959233, Maine 4971068 04412
Contact:
Site Public Contact
800-987-3005

UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen 4346913, Maryland 4361885 21001
Contact:
Site Public Contact
443-643-1029
nfadrwoski@umm.edu

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

Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204
Contact:
Site Public Contact
443-849-3706

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore 4347778, Maryland 4361885 21237
Contact:
Site Public Contact
443-777-7364

MedStar Good Samaritan Hospital
Baltimore 4347778, Maryland 4361885 21239
Contact:
Site Public Contact
410-261-8151
Barbara.rector@medstar.net

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

UPMC Western Maryland
Cumberland 4352681, Maryland 4361885 21502
Contact:
Site Public Contact
240-964-1400

MedStar Montgomery Medical Center
Olney 4364537, Maryland 4361885 20832
Contact:
Site Public Contact
855-546-1944

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

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

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

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

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

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

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

Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing 4998830, Michigan 5001836 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Muskegon Hospital
Muskegon 5003132, Michigan 5001836 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles 5003514, Michigan 5001836 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores 5004005, Michigan 5001836 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Hope Cancer Center
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

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

Corewell Health Reed City Hospital
Reed City 5006946, Michigan 5001836 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph 5008327, Michigan 5001836 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph 5008327, Michigan 5001836 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Munson Medical Center
Traverse City 5012495, Michigan 5001836 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

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

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

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

Sanford Thief River Falls Medical Center
Thief River Falls 5049970, Minnesota 5037779 56701
Contact:
Site Public Contact
605-312-3320

Sanford Cancer Center Worthington
Worthington 5053460, Minnesota 5037779 56187
Contact:
Site Public Contact
605-312-3320

Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin 4375663, Missouri 4398678 63011
Contact:
Site Public Contact
888-446-3729

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

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

University Health Truman Medical Center
Kansas City 4393217, Missouri 4398678 64108
Contact:
Site Public Contact
816-404-4375

University of Kansas Cancer Center - Briarcliff
Kansas City 4393217, Missouri 4398678 64116
Contact:
Site Public Contact
913-588-3671

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

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

Lake Regional Hospital
Osage Beach 4402040, Missouri 4398678 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

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

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

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

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

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

Community Hospital of Anaconda
Anaconda 5637146, Montana 5667009 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

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

Benefis Sletten Cancer Institute
Great Falls 5655240, Montana 5667009 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula 5666639, Montana 5667009 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Jefferson Cherry Hill Hospital
Cherry Hill 4501198, New Jersey 5101760 08002
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Sidney Kimmel Cancer Center Washington Township
Sewell 4504048, New Jersey 5101760 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

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

UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Novant Health Presbyterian Medical Center
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Margaret R Pardee Memorial Hospital
Hendersonville 4470592, North Carolina 4482348 28791
Contact:
Site Public Contact
828-696-4716
pardeecancerresearch@unchealth.unc.edu

Novant Health Cancer Institute - Huntersville
Huntersville 4472370, North Carolina 4482348 28078
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Kernersville
Kernersville 4474221, North Carolina 4482348 27284
Contact:
Site Public Contact
336-718-8335
asmarrs@novanthealth.org

Novant Health Cancer Institute - Matthews
Matthews 4478334, North Carolina 4482348 28105
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Mooresville
Mooresville 4480125, North Carolina 4482348 28117
Contact:
Site Public Contact
980-201-6360
kashah@novanthealth.org

Novant Health Cancer Institute - Mount Airy
Mount Airy 4480378, North Carolina 4482348 27030
Contact:
Site Public Contact
336-718-8335
asmarrs@novanthealth.org

FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst 4485272, North Carolina 4482348 28374
Contact:
Site Public Contact
910-715-3500
jcwilliams@firsthealth.org

Novant Health Cancer Institute - Thomasville
Thomasville 4494942, North Carolina 4482348 27360
Contact:
Site Public Contact
336-718-8335
pjordan@novanthealth.org

Novant Health Forsyth Medical Center
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Site Public Contact
336-718-8335
pjordan@novanthealth.org

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

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

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

Aultman Health Foundation
Canton 5149222, Ohio 5165418 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

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

University of Cincinnati Cancer Center-West Chester
West Chester 4520522, Ohio 5165418 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

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

Providence Hood River Memorial Hospital
Hood River 5731777, Oregon 5744337 97031
Contact:
Site Public Contact
503-215-1979
canrsrchstudies@provdience.org

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

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

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

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

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

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

UPMC-Heritage Valley Health System Beaver
Beaver 5179446, Pennsylvania 6254927 15009
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Hillman Cancer Center at Butler Health System
Butler 5182534, Pennsylvania 6254927 16001
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

WellSpan Medical Oncology and Hematology
Chambersburg 4557109, Pennsylvania 6254927 17201
Contact:
Site Public Contact
717-217-6020

UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township 8643098, Pennsylvania 6254927 16066
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Ephrata Cancer Center
Ephrata 5188815, Pennsylvania 6254927 17522
Contact:
Site Public Contact
717-721-4840

UPMC Hillman Cancer Center Erie
Erie 5188843, Pennsylvania 6254927 16505
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Cancer Center at UPMC Horizon
Farrell 5189377, Pennsylvania 6254927 16121
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Adams Cancer Center
Gettysburg 4558183, Pennsylvania 6254927 17325
Contact:
Site Public Contact
877-441-7957

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg 5192029, Pennsylvania 6254927 15601
Contact:
Site Public Contact
724-838-1900

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg 5192726, Pennsylvania 6254927 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

IRMC Cancer Center
Indiana 5194868, Pennsylvania 6254927 15701
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown 5195561, Pennsylvania 6254927 15901
Contact:
Site Public Contact
814-534-4724

Sechler Family Cancer Center
Lebanon 5197517, Pennsylvania 6254927 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

UPMC Cancer Center at UPMC McKeesport
McKeesport 5200499, Pennsylvania 6254927 15132
Contact:
Site Public Contact
412-647-8073

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Hillman Cancer Center - Monroeville
Monroeville 5201734, Pennsylvania 6254927 15146
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania 6254927 15642
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Hillman Cancer Center - New Castle
New Castle 5203127, Pennsylvania 6254927 16105
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Jefferson Torresdale Hospital
Philadelphia 4560349, Pennsylvania 6254927 19114
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

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

UPMC-Saint Margaret
Pittsburgh 5206379, Pennsylvania 6254927 15215
Contact:
Site Public Contact
412-784-4900

UPMC-Passavant Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15237
Contact:
Site Public Contact
412-367-6454

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15243
Contact:
Site Public Contact
412-502-3920

UPMC Cancer Center at UPMC Northwest
Seneca 5211432, Pennsylvania 6254927 16346
Contact:
Site Public Contact
814-676-7900

UPMC Cancer Center-Uniontown
Uniontown 4561859, Pennsylvania 6254927 15401
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

UPMC Cancer Center-Washington
Washington 5218069, Pennsylvania 6254927 15301
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

UPMC West Mifflin-Cancer Center Jefferson
West Mifflin 5218802, Pennsylvania 6254927 15122
Contact:
Site Public Contact
412-653-8100

Divine Providence Hospital
Williamsport 5219585, Pennsylvania 6254927 17754
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Asplundh Cancer Pavilion
Willow Grove 5219619, Pennsylvania 6254927 19090
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Cancer Care Associates of York
York 4562407, Pennsylvania 6254927 17403
Contact:
Site Public Contact
717-741-9229

WellSpan Health-York Cancer Center
York 4562407, Pennsylvania 6254927 17403
Contact:
Site Public Contact
877-441-7957

Smilow Cancer Hospital Care Center - Westerly
Westerly 5225631, Rhode Island 5224323 02891
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Prisma Health Cancer Institute - Spartanburg
Boiling Springs 4571805, South Carolina 4597040 29316
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Easley
Easley 4577263, South Carolina 4597040 29640
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Butternut
Greenville 4580543, South Carolina 4597040 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Faris
Greenville 4580543, South Carolina 4597040 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Eastside
Greenville 4580543, South Carolina 4597040 29615
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Greer
Greer 4580599, South Carolina 4597040 29650
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Seneca
Seneca 4595346, South Carolina 4597040 29672
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

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

Rapid City Regional Hospital
Rapid City 5768233, South Dakota 5769223 57701
Contact:
Site Public Contact
605-755-2370
research@monument.health

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

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

Centra Alan B Pearson Regional Cancer Center
Lynchburg 4771075, Virginia 6254928 24501
Contact:
Site Public Contact
434-200-1495
Kevin.Patel@centrahealth.com

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

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

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

Virginia Cancer Institute
Richmond 4781708, Virginia 6254928 23229
Contact:
Site Public Contact
804-287-3000
smoore@vacancer.com

VCU Massey Cancer Center at Stony Point
Richmond 4781708, Virginia 6254928 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Site Public Contact
804-628-6430
CTOclinops@vcu.edu

VCU Community Memorial Health Center
South Hill 4786619, Virginia 6254928 23970
Contact:
Site Public Contact
nemer.elmouallem@vcuhealth.org

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

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

Edwards Comprehensive Cancer Center
Huntington 4809537, West Virginia 4826850 25701
Contact:
Site Public Contact
304-399-6566
Christina.Cole@chhi.org

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

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

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay 5254962, Wisconsin 5279468 54303
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison 5261457, Wisconsin 5279468 53718
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468 53792
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Aspirus Medford Hospital
Medford 5262475, Wisconsin 5279468 54451
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

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

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

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

Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls 5265522, Wisconsin 5279468 54154
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

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

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

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

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

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

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

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

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

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

Centro Comprensivo de Cancer de UPR
San Juan 4568127, Puerto Rico 00927
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

PROncology
San Juan 4568127, Puerto Rico 00927
Contact:
Site Public Contact
787-919-7919
info@PRoncology.com

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

More Details

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.