Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma
About this trial
This is an interventional treatment trial for HER2/Neu Positive
Eligibility Criteria
Inclusion Criteria:
- Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer; (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer)
- Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, tubal ligation, vasectomized partner, or abstinence) during therapy and for at least 6 months (Arm 1 patients) and for at least 7 months (Arm 2 patients) after the last dose of study therapy (chemotherapy or trastuzumab)
- Submission of tumor samples from the breast surgery is required for all patients; therefore, the local pathology department policy regarding release of tumor samples must be considered in the screening process; patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-47 trial
- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
- Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:
- By pathologic evaluation, primary tumor must be pT1-3
By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
If pN0, one of the following criteria must be met:
- pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative; or
- pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX Recurrence Score of >= 25; or
- pT3 regardless of hormone receptor status, histologic grade, and Oncotype DX Recurrence Score
HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low as defined below
- IHC must be performed and the IHC staining results must indicate a score of 1+ (in situ hybridization [ISH] testing is not required) or 2+ (ISH must also be performed and must indicate that the tumor is HER2-low as described below)
- If ISH testing is performed, test results must be as follows and IHC must be 1+ or 2+: the ratio of HER2 to chromosome enumeration probe 17 (CEP17) must be < 2.0 or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus
- Note: If the IHC staining intensity is reported as a range, e.g., 0 to 1+ or 1+ to 2+, the higher intensity score in the range should be used to determine eligibility
- The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy); (patients who have had a nipple-sparing mastectomy are eligible)
- For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
- For patients who undergo mastectomy, margins must be free of gross residual tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)
The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below:
Sentinel lymphadenectomy alone:
- If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b
- If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a, the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes
- Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
- Axillary lymphadenectomy with or without SN isolation procedures
- The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days
- The patient must have ER analysis performed on the primary tumor prior to randomization; if ER analysis is negative, then PgR analysis must also be performed (either the core biopsy or surgical resection specimen can be used for ER/PgR testing); patients with a primary tumor that is hormone receptor-positive or receptor-negative are eligible
- Absolute neutrophil count (ANC) must be >= 1,200/mm^3
- Platelet count must be >= 100,000/mm^3
- Hemoglobin must be >= 10 g/dL
- Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert disease or similar syndrome involving slow conjugation of bilirubin
- Alkaline phosphatase must be =< 2.5 x ULN for the lab
- Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab (if alanine aminotransferase [ALT] is performed instead of AST [per institution's standard practice], the alanine aminotransferase [ALT] value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN)
- Alkaline phosphatase and AST may not both be > the ULN
- Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the above requirements are met
- Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease
- The most recent postoperative serum creatinine performed within 6 weeks prior to randomization must be =< ULN for the lab
Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; LVEF assessment performed by 2-dimensional (D) echocardiogram is preferred, however, multi-gated acquisition (MUGA) scan maybe substituted based on institutional preferences
- For patients who will receive the TC chemotherapy regimen, the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal
- For patients who will receive the AC-->WP chemotherapy regimen, the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal
- NOTE: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments, it is critical that this baseline study be an accurate assessment; if the baseline LVEF is > 70%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and repeat the test if the accuracy is uncertain
Exclusion Criteria:
Primary tumor with any of the following HER2 testing results:
IHC staining intensity:
- 0 on all evaluations of specimens
- 3+ on evaluation of any specimen
- ISH with a ratio of HER2 to CEP17 >= 2.0 on evaluation of any specimen
- ISH result indicating HER2 gene copy number >= 4 per nucleus on evaluation of any specimen
- T4 tumors including inflammatory breast cancer
Definitive clinical or radiologic evidence of metastatic disease
- NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization
- Synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
- Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
- Previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy
- Chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization
- Whole-breast RT prior to randomization or partial-breast RT that cannot be completed on or before the date of randomization
- Continued endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor; patients are eligible if these medications are discontinued prior to randomization
- Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
Active cardiac disease:
- Angina pectoris that requires the current use of anti-anginal medication
- Ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
- Conduction abnormality requiring a pacemaker
- Valvular disease with documented compromise in cardiac function
- Symptomatic pericarditis
History of cardiac disease:
- Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function
- History of documented congestive heart failure (CHF)
- Documented cardiomyopathy
Hypertension defined according to the following ineligibility criteria:
- For patients who will receive TC (regardless of the patient's age): uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
- For patients < 50 years old who will receive AC-->WP: uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
For patients >= 50 years old who will receive AC-->WP:
- Uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
- Controlled hypertension (systolic BP =< 150 mm Hg and diastolic BP =< 90 mmHg), if anti-hypertensive medication(s) are needed
- NOTE: Patients who are not eligible based on the AC-WP regimen BP criteria but who meet the TC regimen BP criteria are eligible for B-47, if the intended chemotherapy regimen is changed to TC
- Active hepatitis B or hepatitis C with abnormal liver function tests
- Intrinsic lung disease resulting in dyspnea
- Poorly controlled diabetes mellitus
- Active infection or chronic infection requiring chronic suppressive antibiotics
- Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
- Conditions that would prohibit administration of corticosteroids
- Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisol one equivalent (excluding inhaled steroids)
- Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor EL
- Pregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
- Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- Use of any investigational product within 30 days prior to randomization
Sites / Locations
- Northeast Alabama Regional Medical Center
- Providence Hospital
- University of South Alabama Mitchell Cancer Institute
- Alaska Breast Care and Surgery LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Arizona Oncology Associates-Biltmore Cancer Center
- Virginia G Piper Cancer Care-Del Camino
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- NEA Baptist Memorial Hospital
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- Sutter Davis Hospital
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fontana
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Kaiser Permanente-Fresno
- Glendale Memorial Hospital and Health Center
- Marin Cancer Care Inc
- Marin General Hospital
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente West Los Angeles
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Community Hospital of Monterey Peninsula
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- Ventura County Hematology Oncology Specialists
- Desert Regional Medical Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente - Panorama City
- Valley Medical Oncology Consultants
- Pomona Valley Hospital Medical Center
- Kaiser Permanente-Rancho Cordova Cancer Center
- Eisenhower Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- Salinas Valley Memorial
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Breastlink Medical Group Inc
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Northbay Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- Kaiser Permanente-Woodland Hills
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Manchester Memorial Hospital
- Midstate Medical Center
- Middlesex Hospital
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- Smilow Cancer Hospital Care Center - Waterford
- Bayhealth Hospital Kent Campus
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- Kaiser Permanente-Capitol Hill Medical Center
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- AdventHealth Altamonte
- Halifax Health Medical Center-Centers for Oncology
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- Broward Health Medical Center
- University of Florida Health Science Center - Gainesville
- Saint Vincent's Medical Center
- Baptist MD Anderson Cancer Center
- Jupiter Medical Center
- AdventHealth Kissimmee
- Lakeland Regional Health Hollis Cancer Center
- The Watson Clinic
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Ocala Oncology Center
- 21st Century Oncology-Orange Park
- AdventHealth Medical Group Urology at Orlando
- AdventHealth Orlando
- Orlando Health Cancer Institute
- AdventHealth East Orlando
- Florida Cancer Specialists - Sarasota Downtown
- AdventHealth Winter Park
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Grady Health System
- Emory University Hospital Midtown
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- Augusta University Medical Center
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Dublin Hematology Oncology Care PC
- Piedmont Fayette Hospital
- Northside Hospital - Gwinnett
- Medical Center of Central Georgia
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Low Country Cancer Care
- Memorial Health University Medical Center
- Summit Cancer Care-Memorial
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Joseph Regional Medical Center
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Portneuf Medical Center
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Mac Neal Hospital
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Illinois
- Swedish Covenant Hospital
- Presence Resurrection Medical Center
- Weiss Memorial Hospital
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Advocate Good Samaritan Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Ascension Alexian Brothers - Elk Grove Village
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Saint Francis Hospital
- Freeport Memorial Hospital/Leonard C Ferguson Cancer Center
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- Duly Health and Care Joliet
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Medical Center
- Swedish American Hospital
- OSF Saint Anthony Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Illinois CancerCare-Spring Valley
- Central Illinois Hematology Oncology Center
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Ascension Saint Vincent Anderson
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Community Cancer Center East
- Franciscan Health Indianapolis
- Community Cancer Center North
- Ascension Saint Vincent Indianapolis Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Cancer Care Partners LLC
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- IU Health Ball Memorial Hospital
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Physicians' Clinic of Iowa PC
- Saint Luke's Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Genesis Medical Center - East Campus
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- MercyOne Waterloo Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Baptist Health Corbin
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Baptist Health Hardin
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Jewish Hospital
- Norton Hospital Pavilion and Medical Campus
- The James Graham Brown Cancer Center at University of Louisville
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Owensboro Health Mitchell Memorial Cancer Center
- Jewish Hospital Medical Center South
- Christus Saint Frances Cabrini Hospital
- Baton Rouge General Medical Center
- Hematology/Oncology Clinic PLLC
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- West Jefferson Medical Center
- Robert Veith MD LLC
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- University Medical Center New Orleans
- Ochsner Baptist Medical Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Highland Clinic
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Mercy Hospital
- Penobscot Bay Medical Center
- Maine Center for Cancer Medicine-Scarborough
- York Hospital
- Anne Arundel Medical Center
- University of Maryland/Greenebaum Cancer Center
- Veterans Administration Medical Center-Baltimore
- Mercy Medical Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- MedStar Harbor Hospital
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Kaiser Permanente-Woodlawn Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- UM Upper Chesapeake Medical Center
- Suburban Hospital
- Walter Reed National Military Medical Center
- Maryland Oncology Hematology PA-Columbia
- UPMC Western Maryland
- University of Maryland Shore Medical Center at Easton
- Christiana Care - Union Hospital
- Frederick Memorial Hospital
- Kaiser Permanente-Gaithersburg Medical Center
- Meritus Medical Center
- Kaiser Permanente - Largo Medical Center
- Northwest Hospital Center
- Kaiser Permanente - Shady Grove Medical Center
- Maryland Oncology Hematology PA-Aquilino Cancer Center
- TidalHealth Peninsula Regional
- Holy Cross Hospital
- UM Saint Joseph Medical Center
- Sturdy Memorial Hospital
- Beverly Hospital
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Boston Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Mount Auburn Hospital
- Mass General/North Shore Cancer Center
- Southcoast Centers for Cancer Care-Fairhaven
- Saint Anne's Hospital
- MetroWest Medical Center-Framingham Union Hospital
- Addison Gilbert Hospital
- Lowell General Hospital
- Holy Family Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Newton-Wellesley Hospital
- Berkshire Medical Center - Cancer Center
- Dana Farber Community Cancer Care-Quincy
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Spectrum Health Big Rapids Hospital
- McLaren Cancer Institute-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Huron Valley-Sinai Hospital
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Michigan State University Clinical Center
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- Lapeer Regional Hospital
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- MyMichigan Medical Center Midland
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- University of Michigan Health - West
- Medini, Eitan MD (UIA Investigator)
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Gulfport Memorial Hospital
- Hattiesburg Clinic - Hematology/Oncology Clinic
- Forrest General Hospital / Cancer Center
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Comprehensive Cancer Care PC
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Southeast Nebraska Cancer Center - 68th Street Place
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Cancer Alliance of Nebraska
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Regional West Medical Center Cancer Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- New Hampshire Oncology Hematology PA-Concord
- Exeter Hospital
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Norris Cotton Cancer Center-Manchester
- Solinsky Center for Cancer Care
- Dartmouth Cancer Center - Nashua
- Cooper Hospital University Medical Center
- Hunterdon Medical Center
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Morristown Medical Center
- Virtua Memorial
- Inspira Medical Center Mullica Hill
- Jersey Shore Medical Center
- Rutgers New Jersey Medical School
- Newark Beth Israel Medical Center
- Saint Joseph's Regional Medical Center
- Sidney Kimmel Cancer Center Washington Township
- Robert Wood Johnson University Hospital Somerset
- Sparta Cancer Treatment Center
- Overlook Hospital
- Community Medical Center
- Inspira Medical Center Vineland
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- Lovelace Medical Center-Saint Joseph Square
- University of New Mexico Cancer Center
- Hematology Oncology Associates
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- New York Oncology Hematology PC - Albany
- New York Oncology Hematology PC - Albany Medical Center
- Saint Peter's Health Partners
- New York Oncology Hematology PC - Amsterdam
- Hematology Oncology Associates of Central New York-Auburn
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Coney Island Hospital
- Roswell Park Cancer Institute
- New York Oncology Hematology PC - Clifton Park
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York-East Syracuse
- Elmhurst Hospital Center
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls Hospital
- New York Oncology Hematology PC-Hudson
- Queens Hospital Center
- Northwell Health NCORP
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Garnet Health Medical Center
- NYU Winthrop Hospital
- Mount Kisco Medical Group at Northern Westchester Hospital
- Long Island Jewish Medical Center
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- Mount Sinai Hospital
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- MidHudson Regional Hospital of Westchester Medical Center
- Vassar Brothers Medical Center
- Highland Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Staten Island University Hospital
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Hematology Oncology Associates of Central New York-Onondaga Hill
- New York Oncology Hematology PC - Troy
- Faxton-Saint Luke's Healthcare
- Dickstein Cancer Treatment Center
- Randolph Hospital
- Mission Hospital
- Mountain Radiation Oncology PA
- AdventHealth Infusion Center Asheville
- Messino Cancer Centers
- Hope Women's Cancer Centers-Asheville
- Transylvania Regional Hospital
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Novant Health Carolina Surgical - Randolph
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Cape Fear Valley Health System
- Angel Medical Center
- CaroMont Regional Medical Center
- Gaston Hematology and Oncology Associates
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- Maria Parham Hospital
- Novant Health Cancer Institute - Huntersville
- Southern Oncology Specialists-Huntersville
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Novant Health Cancer Institute - Kernersville
- Vidant Oncology-Kinston
- Scotland Memorial Hospital-Laurinburg Cancer Center
- Southeastern Regional Medical Center
- Mission Hospital McDowell
- Matthews Radiation Oncology Center
- Novant Health Cancer Institute - Matthews
- Cone Heath Cancer Center at Mebane
- Atrium Health Union/LCI-Union
- Novant Health Cancer Institute - Mooresville
- Novant Health Cancer Institute - Mount Airy
- Granville Medical Center
- FirstHealth of the Carolinas-Moore Regional Hospital
- UNC Rex Healthcare
- Duke Raleigh Hospital
- UNC Rex Cancer Center of Wakefield
- Annie Penn Memorial Hospital
- Nash General Hospital
- Person Memorial Hospital
- Rutherford Hospital
- Atrium Health Cleveland/LCI-Cleveland
- Cleveland Hematology and Oncology Associates PC
- Johnston Memorial Hospital
- Blue Ridge Regional Hospital
- Novant Health Cancer Institute - Statesville
- Iredell Memorial Hospital
- Novant Health Cancer Institute - Thomasville
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Novant Health Cancer Institute - Wilkesboro
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Winston-Salem Health Care
- Southeast Clinical Oncology Research Consortium NCORP
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Summa Health System - Barberton Campus
- Cleveland Clinic Cancer Center Beachwood
- UHHS-Chagrin Highlands Medical Center
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- The Christ Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Saint Rita's Medical Center
- Lima Memorial Hospital
- OhioHealth Mansfield Hospital
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- South Pointe Hospital
- Fulton County Health Center
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- Clinton Memorial Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Integris Southwest Medical Center
- Integris Cancer Institute of Oklahoma
- Natalie Warren Bryant Cancer Center at Saint Francis
- Surgical Associates Inc
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Warren Clinic Oncology-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Three Rivers Community Hospital
- Legacy Mount Hood Medical Center
- Asante Health System
- Providence Medford Medical Center
- Rogue Valley Medical Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Legacy Emanuel Hospital and Health Center
- Salem Hospital
- Mid-Columbia Medical Center/Celilo Cancer Center
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Butler Memorial Hospital
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Doylestown Hospital
- Delaware County Memorial Hospital
- Oncology Hematology Associates of Northern Pennsylvania
- Einstein Medical Center Montgomery
- Pocono Medical Center
- Easton Hospital
- Ephrata Cancer Center
- Ephrata Community Hospital
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Saint Mary Medical and Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- Holy Redeemer Hospital and Medical Center
- Riddle Memorial Hospital
- Forbes Hospital
- UPMC Hillman Cancer Center in Coraopolis
- Allegheny Valley Hospital
- Suburban Community Hospital and Cancer Center
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Temple University Hospital
- Einstein Medical Center Philadelphia
- Mercy Hospital of Philadelphia
- Phoenixville Hospital
- Allegheny General Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Hospital
- Geisinger Cancer Services-Pottsville
- Penn State Health Saint Joseph Medical Center
- Guthrie Medical Group PC-Robert Packer Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Grand View Hospital
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- Mount Nittany Medical Center
- UPMC Uniontown Hospital Radiation Oncology
- Associates In Hematology Oncology PC-Upland
- UPMC Washington Hospital Radiation Oncology
- Chester County Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Hospital
- Rhode Island Hospital
- Women and Infants Hospital
- Miriam Hospital
- Kent Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Beaufort Memorial Hospital
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Charleston Oncology - Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Charleston Oncology - Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Medical University of South Carolina
- Tidelands Georgetown Memorial Hospital
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Carolina Blood and Cancer Care Associates PA
- Levine Cancer Institute-Rock Hill
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Avera Cancer Institute-Aberdeen
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Bristol Regional Medical Center
- Wellmont Medical Associates Oncology and Hematology-Bristol
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- Meharry Medical College
- Memorial GYN Plus
- Hendrick Medical Center
- Texas Oncology PA - Amarillo
- Dell Seton Medical Center at The University of Texas
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology-Austin North
- Texas Oncology - Beaumont
- Texas Oncology Bedford
- Texas Oncology-Cedar Park
- Texas Cancer Center - Medical City Dallas
- Texas Health Presbyterian Hospital Dallas
- UT Southwestern/Simmons Cancer Center-Dallas
- Texas Oncology - Denison Cancer Center
- Texas Oncology-Denton South
- Texas Oncology-El Paso
- Texas Oncology-Flower Mound
- Texas Oncology - Fort Worth Cancer Center
- University of Texas Medical Branch
- Texas Oncology - Garland
- Texas Oncology-Grapevine
- Memorial Hermann Memorial City Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Houston Methodist Hospital
- Texas Oncology-Kyle Hays
- Doctor's Hospital of Laredo
- UTMB Cancer Center at Victory Lakes
- Texas Oncology - Lewisville
- Texas Oncology-Longview Cancer Center
- Texas Oncology-McAllen
- Texas Cancer Center - Mesquite
- North Texas Regional Cancer Center
- Texas Oncology-Plano West
- Texas Oncology - Round Rock Cancer Center
- Cancer Care Centers of South Texas- Northeast
- Cancer Care Centers of South Texas
- University of Texas Health Science Center at San Antonio
- Texas Oncology- San Marcos
- Scott and White Memorial Hospital
- Memorial Hermann The Woodlands Hospital
- The US Oncology Network
- Tyler Cancer Center
- Texas Oncology-Waco Highway 6
- Texas Oncology-Wichita Falls Texoma Cancer Center
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Southwestern Vermont Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont and State Agricultural College
- Rutland Regional Medical Center
- Norris Cotton Cancer Center-North
- Kaiser Permanente-Burke Medical Center
- Sentara Martha Jefferson Hospital
- Danville Regional Medical Center
- Kaiser Permanente - Fair Oaks Medical Center
- Augusta Health Center for Cancer and Blood Disorders
- Fredericksburg Oncology Inc
- Hematology Oncology Associates of Fredericksburg Inc
- Peninsula Cancer Institute-Gloucester
- Virginia Oncology Associates-Hampton
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Kaiser Permanente Tysons Corner Medical Center
- Peninsula Cancer Institute-Newport News
- Southwest VA Regional Cancer Center
- Virginia Cancer Institute
- Virginia Commonwealth University/Massey Cancer Center
- Peninsula Cancer Institute-Cancer Specialists of Tidewater
- Peninsula Cancer Institute-Williamsburg
- Shenandoah Oncology PC
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Overlake Internal Medicine Associates
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- EvergreenHealth Medical Center
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Skagit Regional Health Cancer Care Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Virginia Mason Medical Center
- Harborview Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Olympic Medical Cancer Care Center
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- Cancer Care Northwest - Spokane South
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- Cancer Care Northwest-Valley
- Cancer Care Northwest-North Spokane
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- United Hospital Center
- West Virginia University Charleston Division
- Fairmont Regional Cancer Center
- Edwards Comprehensive Cancer Center
- Saint Mary's Medical Center
- WVUH-Berkely Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Princeton Community Hospital
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Saint Agnes Hospital/Agnesian Cancer Center
- Aurora Health Center-Fond du Lac
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Mercyhealth Hospital and Cancer Center - Janesville
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Ascension Columbia Saint Mary's Hospital Ozaukee
- Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
- Ascension Columbia Saint Mary's Hospital - Milwaukee
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Ascension Saint Clare's Hospital
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Welch Cancer Center
- Tom Baker Cancer Centre
- CHUM - Hopital Notre-Dame
- CHUM-Hotel Dieu de Montreal
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Montreal General Hospital
- The Research Institute of the McGill University Health Centre (MUHC)
- Jewish General Hospital
- Saint Mary's Hospital
- CHU de Quebec-Hopital du Saint-Sacrement (HSS)
- Bon Secours Hospital
- Tallaght University Hospital
- Saint Vincent's University Hospital
- Mater Misericordiae University Hospital
- Mater Private Hospital
- Beaumont Hospital
- Saint Vincent's Private Hospital
- University College Hospital Galway
- Mid-Western Regional Hospital
- Sligo University Hospital
- University Hospital Waterford
- Cork University Hospital
- Saint James Hospital
- Letterkenny General Hospital
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (chemotherapy)
Arm II (chemotherapy, trastuzumab)
GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.
GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.