Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, HER2-negative breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer
Eligibility Criteria
Inclusion Criteria:
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- The breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative based on current American Society of Clinical Oncology (ASCO)/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ hybridization [CISH], or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy.
All of the following staging criteria must be met according to American Joint Committee on Cancer (AJCC) criteria:
- By pathologic evaluation, primary tumor must be pT1-3;
- By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
- If pN0, at least one of the following criteria must be met:
- ER negative and PgR negative; or
- Pathologic tumor size greater than 2.0 cm; or
- T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of greater than or equal to 25.
- Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy).
- 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 must 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 histologically free of invasive tumor and DCIS.
Patients must have completed one of the following procedures for evaluation of pathologic nodal status:
- Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b;
- Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN1a limited to 1 or 2 positive nodes and primary tumor is T1 or T2 by pathologic evaluation;
- 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 procedure.
- The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days.
- Patients must have ER analysis performed on the primary tumor prior to randomization. Breast cancer must be assessed for ER status by current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. (Either a core biopsy or surgical resection specimen can be used for ER/PgR testing.)
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria:
- absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3;
- platelet count must be greater than or equal to 100,000/mm3; and
- hemoglobin must be greater than or equal to 10 g/dL.
The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization:
- total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
- alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and
- aspartate transaminase (AST) must be less than or equal to 1.5 x ULN for the lab.
- Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2.5 x ULN, then the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, then the alkaline phosphatase must be less than or equal to ULN.
- Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be less than or equal to 1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x ULN.
- Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan performed within 90 days prior to randomization) does not demonstrate metastatic disease and the requirements for adequate hepatic function as described above are met.
- Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN 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 less than or equal to ULN for the lab.
- Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multigated acquisition (MUGA) scan must be performed within 90 days prior to randomization. The LVEF must be greater than or equal to 50% regardless of the facility's lower limit of normal (LLN). (If the facility performing the assessment has not reported the LVEF as a whole number, decimals reported as greater than or equal to 5 should be rounded up and decimals reported as less than 5 should be rounded down.)
Exclusion criteria:
Patients with one or more of the following conditions are ineligible for this study.
- T4 tumors including inflammatory breast cancer.
- Definitive clinical or radiologic evidence of metastatic disease. (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 are eligible.)
- Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.
- History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
- Previous therapy with anthracyclines or taxanes for any malignancy.
- Chemotherapy administered for the currently diagnosed breast cancer prior to randomization.
- Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. Patients are eligible if these medications are discontinued prior to randomization.
- Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.
- Known active hepatitis B or hepatitis C with abnormal liver function tests.
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 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 ventricular function;
- history of documented congestive heart failure (CHF);
- documented cardiomyopathy.
- Whole breast radiation therapy (RT) prior to randomization or partial breast RT that cannot be completed on or before the date of randomization.
- Intrinsic lung disease resulting in dyspnea.
- Unstable diabetes mellitus.
- Active infection or chronic infection requiring suppressive antibiotics.
- History of a major organ allograft or condition requiring chronic immunosuppression, e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases. (Patients who have received corneal transplants, cadaver skin, or bone transplants are eligible.)
- Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) greater than or equal to grade 2, per the NCI CTCAE v4.0.
- Conditions that would prohibit administration of corticosteroids.
- Chronic daily treatment with corticosteroids (dose of greater than or equal to 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
- History of hypersensitivity reaction to drugs formulated with polysorbate 80.
- 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
- Providence Alaska Medical Center
- Arizona Oncology Associates-Biltmore Cancer Center
- Premiere Oncology of Arizona
- Sedona Medical Center
- Arizona Oncology Associates
- NEA Baptist Clinic-Matthews
- Kaiser Anaheim Medical Center
- Kaiser Permanente-Deer Valley Medical Center
- Kaiser Permanente Medical Group - Baldwin Park
- Kaiser Foundation Hospital
- Providence Saint Joseph Medical Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- Epic Care-Dublin
- Northbay Cancer Center
- Kaiser Permanente Hospital
- Kaiser Permanente, Fremont
- Valley Medical Oncology Consultants-Fremont
- Washington Hospital
- California Cancer Center - North Fresno
- Kaiser Permanente
- Kaiser Permanente - Harbor City
- Kaiser Permanente, Hayward
- Southern California Permanente Medical Group
- UC San Diego Moores Cancer Center
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente
- Kaiser Permanente-West Los Angeles
- Cedars-Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Community Hospital of Monterey Peninsula
- El Camino Hospital
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons Inc
- Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Epic Care-Oakland
- Desert Regional Medical Center
- Kaiser Permanente - Panorama City
- Feather River Cancer Center
- East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
- Pomona Valley Hospital Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente Medical Center
- Kaiser Permanente-Roseville
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- Kaiser Permanente at San Diego
- Naval Medical Center -San Diego
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Santa Clara Valley Medical Center
- Kaiser Permanente Health Care
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Stanford University Hospitals and Clinics
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Presbyterian Intercommunity Hospital
- Kaiser Permanente
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Saint Anthony Central Hospital
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- North Colorado Medical Center
- Kaiser Permanente-Rock Creek
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- University of Connecticut
- Hartford Hospital
- Saint Francis Hospital and Medical Center
- Manchester Memorial Hospital
- Midstate Medical Center
- Middlesex Hospital
- The Hospital of Central Connecticut
- Stamford Hospital
- Bayhealth Medical Center at Kent General
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Nanticoke Memorial Hospital
- Kaiser Permanente-Capitol Hill Medical Center
- Washington Hospital Center
- Sibley Memorial Hospital
- George Washington University Medical Center
- Lombardi Comprehensive Cancer Center at Georgetown University
- Morton Plant Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- Saint Vincent's Medical Center
- Edna Williams Cancer Center at the Baptist Cancer Institute
- Jupiter Medical Center
- Lakeland Regional Cancer Center
- The Watson Clinic
- Mount Sinai Medical Center CCOP
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Advanced Medical Specialties -North
- Ocala Oncology Center
- Florida Hospital
- M D Anderson Cancer Center- Orlando
- Sacred Heart Hospital
- Sacred Heart Medical Oncology Group - Davis Highway
- Piedmont Hospital
- Augusta Oncology Associates PC-Saint Sebastian
- John B Amos Cancer Center
- Dekalb Medical Center
- Northeast Georgia Medical Center
- Memorial Health University Medical Center
- Saint Joseph's-Candler Health System
- South Georgia Medical Center
- Kapiolani Medical Center at Pali Momi
- Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii
- OnCare Hawaii-Liliha
- Kuakini Medical Center
- Oncare Hawaii Inc-Kuakini
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Regional Medical Center
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute PA
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Saint Joseph Medical Center
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- University of Illinois
- Weiss Memorial Hospital
- Decatur Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Evanston CCOP-NorthShore University HealthSystem
- Saint Francis Hospital
- FHN Leonard C. Ferguson Cancer Center
- Illinois CancerCare Galesburg
- Medical and Surgical Specialists
- Illinois CancerCare-Havana
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Hinsdale Hematology Oncology Associates Incorporated
- Joliet Oncology-Hematology Associates Limited
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Adventist La Grange Memorial Hospital
- North Shore Hematology Oncology
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Medical Center
- Edward Hospital/Cancer Center
- Hematology Oncology Consultants Limited
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Mid-Illinois Hematology Oncology Associates
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Advocate Lutheran General Hospital
- Pekin Cancer Treatment Center
- Illinois CancerCare-Pekin
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Cancer Center
- Swedish American Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Illinois CancerCare-Spring Valley
- Memorial Medical Center
- Carle Foundation - Carle Cancer Center
- Saint Francis Hospital and Health Centers
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
- Central Indiana Cancer Centers - Indianapolis
- Franciscan St. Francis Health
- Community Howard Regional Health
- Indiana University Health La Porte Hospital
- IU Health Arnett
- Premier Oncology Hematology Associates
- Saint Anthony Memorial Health Center
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Cancer Care Partners LLC
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- South Bend Clinic
- Michiana Hematology Oncology-PC Westville
- McFarland Clinic
- Constantinou, Costas L MD (UIA Investigator)
- Hematology Oncology Associates-Quad Cities
- Helen G Nassif Community Cancer Center
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Genesis Medical Center - East Campus
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa Hospitals and Clinics
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Covenant Medical 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
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Promise Regional Medical Center-Hutchinson
- Cancer Center of Kansas-Independence
- Kansas City Cancer Center-West
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Kansas City Cancer Centers-Southwest
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Kansas City CCOP
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Kansas City Cancer Center-Shawnee Mission
- Stormont-Vail Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Baptist Regional Medical Center
- Baptist Health Lexington
- University of Kentucky
- Norton Health Care Pavilion - Downtown
- The James Graham Brown Cancer Center at University of Louisville
- Baptist Health Louisville
- Christus Saint Frances Cabrini Hospital
- Hematology/Oncology Clinic LLP
- Mary Bird Perkins Cancer Center
- Ochsner Clinic Foundation-Baton Rouge
- Ochsner North Shore Medical Center
- Interim LSU Public Hospital
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- Ochsner Baptist Medical Center
- Ochsner Clinic CCOP
- Christus Schumpert Saint Mary's Place
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Mercy Hospital
- Penobscot Bay Medical Center
- Maine Center for Cancer Medicine and Blood Disorders-Scarborough
- Anne Arundel Medical Center
- Greater Baltimore Medical Center
- The Union Memorial Hospital
- Saint Agnes Hospital
- Franklin Square Hospital Center
- Kaiser Permanente-Woodlawn Medical Center
- Johns Hopkins University
- Maryland Oncology Hematology PA-Columbia
- The Memorial Hospital at Easton
- Union Hospital of Cecil County
- Frederick Memorial Hospital
- Kaiser Permanente-Gaithersburg Medical Center
- Kaiser Permanente - Largo Medical Center
- Peninsula Regional Medical Center
- Holy Cross Hospital
- Beverly Hospital
- Tufts Medical Center
- Boston Medical Center
- Lahey Hospital and Medical Center
- Saint Anne's Hospital
- Addison Gilbert Hospital
- Lowell General Hospital
- Holy Family Hospital
- Newton-Wellesley Hospital
- Berkshire Hematology Oncology PC
- Jordan Hospital
- Baystate Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- University of Michigan
- Bronson Battle Creek
- Bay Regional Medical Center
- Mecosta County Medical Center
- Great Lakes Cancer Institute
- Oakwood Hospital
- Henry Ford Hospital
- Wayne State University
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Genesys Regional Medical Center-West Flint Campus
- McLaren Regional Cancer Center
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Grand Rapids Clinical Oncology Program
- Saint Mary's Health Care
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Michigan State University - Breslin Cancer Center
- Sparrow Hospital
- Great Lakes Cancer Institute-Lapeer Campus
- Saint Mary Mercy Hospital
- Marquette General Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Mount Clemens Regional Medical Center
- Mercy Health Partners-Mercy Campus
- Memorial Healthcare Center
- Northern Michigan Regional Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Spectrum Health Reed City Hospital
- William Beaumont Hospital
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Providence Hospital
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidgi
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Duluth Clinic CCOP
- 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 System in Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- CentraCare Clinic
- Saint Cloud Hospital
- Metro-Minnesota CCOP
- 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 and Hematology PA-Woodbury
- Gulfport Memorial Hospital
- Forest General Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center-Carrie J Babb Cancer Center
- CoxHealth Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- University of Missouri - Ellis Fischel
- Capital Region Medical Center-Goldschmidt Cancer Center
- Freeman Health System
- Saint John's Regional Medical Center
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Cancer Center - South
- Research Medical Center
- Kansas City Cancer Centers - North
- Kansas City Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Clinic
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Saint Louis University Hospital
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Comprehensive Cancer Care PC
- Saint John's Mercy Medical Center
- Saint Louis-Cape Girardeau CCOP
- Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
- Saint John's Hospital
- Cox Medical Center
- Montana Cancer Consortium CCOP
- Saint Vincent Healthcare
- Hematology-Oncology Centers of the Northern Rockies PC
- Billings Clinic
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Big Sky Oncology
- 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
- Good Samaritan Hospital
- Lincoln Medical Education Foundation Cancer Resource Center
- Missouri Valley Cancer Consortium CCOP
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- Nevada Cancer Research Foundation CCOP
- New Hampshire Oncology-Hematology PA
- New Hampshire Oncology Hematology Associates
- LRGHealthcare-Lakes Region General Hospital
- Saint Joseph Hospital
- Portsmouth Regional Hospital
- Cooper Hospital University Medical Center
- Englewood Hospital and Medical Center
- Hunterdon Medical Center
- Cancer Institute of New Jersey At Hamilton
- Jersey Shore Medical Center
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- Capital Health Medical Center-Hopewell
- Valley Hospital
- Somerset Medical Center
- Sparta Cancer Treatment Center
- Community Medical Center
- South Jersey Healthcare
- Hematology Oncology Associates
- University of New Mexico
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- New Mexico Cancer Care Associates
- New York Oncology Hematology PC - Albany
- New York Oncology Hematology PC -Albany Medical Center
- New York Oncology Hematology PC - Amsterdam
- Albert Einstein College of Medicine
- Montefiore Medical Center
- Kings County Hospital
- State University of New York Downstate Medical Center
- Maimonides Medical Center
- Roswell Park Cancer Institute
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York PC
- New York Oncology Hematology PC-Hudson
- Broome Oncology LLC
- Monter Cancer Center
- New York Oncology Hematology PC - Latham
- North Shore University Hospital
- North Shore-LIJ Health System CCOP
- Winthrop University Hospital
- Long Island Jewish Medical Center
- Mount Sinai Medical Center
- Columbia University Medical Center
- Saint Francis
- Vassar Brothers Medical Center
- University of Rochester
- Staten Island University Hospital
- Stony Brook University Medical Center
- Randolph Hospital
- Mission Hospitals
- Hope Women's Cancer Centers-Asheville
- Alamance Regional Medical Center
- Waverly Hematology Oncology
- Carolinas Medical Center
- Presbyterian Hospital
- Carolinas Medical Center - Northeast
- Gaston Memorial Hospital
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Margaret R Pardee Memorial Hospital
- Park Ridge Hospital Breast Health Center
- Kinston Medical Specialists PA
- Carolinas Medical Center-Union
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Rex Cancer Center
- Rex Cancer Center of Wakefield
- Annie Penn Memorial Hospital
- Rutherford Hospital
- Cleveland Regional Medical Center
- Iredell Memorial Hospital
- Marion L Shepard Cancer Center
- New Hanover Regional Medical Center
- Forsyth Memorial Hospital
- Wake Forest University Health Sciences
- Bismarck Cancer Center
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Altru Cancer Center
- Summa Akron City Hospital
- Akron General Medical Center
- Summa Barberton Hospital
- Cleveland Clinic Cancer Center Beachwood
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Mercy Medical Center
- Aultman Health Foundation
- Adena Regional Medical Center
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Delaware Health Center-Grady Cancer Center
- Grady Memorial Hospital
- Community Health Partners Regional Medical Center
- Hematology Oncology Center Incorporated
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Mansfield General Hospital-MedCentral Health System
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Knox Community Hospital
- Licking Memorial Hospital
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Parma Community General Hospital
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Cleveland Clinic Cancer Center-Strongsville
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Cancer Center at Saint Anne Mercy Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Cleveland Clinic Wooster Specialty Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis HealthCare System
- Cancer Centers of Southwest Oklahoma Research
- Cancer Care Associates-Norman
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Mercy
- Natalie W Bryant Cancer Center
- Clackamas Radiation Oncology Center
- 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
- Columbia River Oncology Program
- Providence Saint Vincent Medical Center
- Kaiser Permanente
- Mid-Columbia Medical Center
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Geisinger Medical Center
- Doylestown Hospital
- Ephrata Cancer Center
- The Regional Cancer Center
- Adams Cancer Center
- Cherry Tree Cancer Center
- PinnacleHealth Fox Chase Regional Cancer Center at Polyclinic Hospital
- Geisinger Medical Center-Cancer Center Hazelton
- Penn State Milton S Hershey Medical Center
- Medical Oncology Associates
- Armstrong Center for Medicine and Health
- Riddle Hospital
- Forbes Regional Hospital
- Alle-Kiski Medical Center
- Paoli Memorial Hospital
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Phoenixville Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- Western Pennsylvania Hospital
- University of Pittsburgh
- Pottstown Memorial Medical Center
- Saint Joseph Medical Center
- Guthrie Clinic-Robert Packer Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Grand View Hospital
- Geisinger Medical Group
- Associates In Hematology Oncology PC-Upland
- Chester County Hospital
- Reading Hospital and Medical Center
- Geisinger Wyoming Valley
- Susquehanna Cancer Center
- Lankenau Hospital
- Mainline Health CCOP
- York Hospital
- Rhode Island Hospital
- Women and Infants Hospital
- Miriam Hospital
- Kent County Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Beaufort Memorial Hospital
- Roper Hospital
- Medical University of South Carolina
- McLeod Regional Medical Center
- Saint Francis Hospital
- Cancer Centers of the Carolinas - Faris
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Memorial Hospital
- Greenville CCOP
- Self Regional Healthcare
- Cancer Centers of the Carolinas-Greer Medical Oncology
- Gibbs Cancer Center-Pelham
- Cancer Centers of the Carolinas - Seneca
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Cancer Centers of the Carolinas - Spartanburg
- Conklin Regional Cancer Center
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Blue Ridge Medical Specialists PC
- Wellmont Bristol Regional Medical Center
- Erlanger Medical Center
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- University of Tennessee - Knoxville
- Texas Cancer Center
- Texas Oncology PA - Amarillo
- Texas Oncology-Arlington South
- Texas Oncology PA Beaumont
- Texas Oncology PA - Bedford
- Saint Joseph Regional Cancer Center
- Texas Cancer Center - Medical City Dallas
- Texas Health Presbyterian Hospital Dallas
- Texas Oncology Methodist Charlton Cancer Center
- Texas Oncology PA
- Texas Oncology-Denton South
- Texas Oncology-El Paso
- Texas Oncology-Flower Mound
- Texas Oncology Fort Worth at 12th Avenue
- Texas Oncology - Garland
- Memorial Hermann Memorial City Medical Center
- Baylor College of Medicine
- Methodist Hospital
- Texas Oncology - Lewisville
- Covenant Medical Center-Lakeside
- Texas Tech University Health Sciences Center
- Texas Oncology-McAllen
- Texas Cancer Center - Mesquite
- Texas Oncology-Midland Allison Cancer Center
- Texas Oncology-Paris
- North Texas Regional Cancer Center
- Scott and White Healthcare Round Rock
- Texas Oncology - Round Rock Cancer Center
- Cancer Care Centers of South Texas- Northeast
- University of Texas Health Science Center at San Antonio
- Texas Cancer Center-Sherman
- Scott and White Memorial Hospital
- US Oncology Research LLC-The Woodlands
- Tyler Cancer Center
- Texas Oncology PA
- American Fork Hospital
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Mountainview Medical
- University of Vermont
- Rutland Regional Medical Center
- Kaiser Permanente-Burke Medical Center
- University of Virginia
- Virginia Cancer Specialists-Fairfax
- Kaiser Permanente - Fair Oaks Medical Center
- Fredericksburg Oncology Inc
- Hematology Oncology Associates of Fredericksburg Inc
- Peninsula Cancer Institute-Gloucester
- Virginia Oncology Associates-Hampton
- Kaiser Permanente Tysons Corner Medical Center
- Peninsula Cancer Institute-Newport News
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University
- Oncology and Hematology Associates of Southwest Virginia
- Community Memorial Health Center
- Peninsula Cancer Institute-Cancer Specialists of Tidewater
- Peninsula Cancer Institute-Williamsburg
- Shenandoah Oncology Associates PC
- Cancer Care Center at Island Hospital
- Auburn Regional Medical Center
- Overlake Hospital Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison Bremerton Hematology and Oncology
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Centralia Hospital
- Puget Sound Cancer Center
- Swedish Medical Center-Edmonds
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Columbia Basin Hematology and Oncology PLLC
- Cascade Cancer Center
- Skagit Valley Hospital Regional Cancer Care Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Harrison Poulsbo Hematology and Oncology
- Good Samaritan Community Hospital
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health
- Group Health Cooperative
- Swedish Medical Center-First Hill
- University of Washington Medical Center
- United General Hospital
- Olympic Medical Cancer Care Center
- Cancer Care Northwest - Spokane South
- Rockwood Cancer Treatment Center
- Cancer Care Northwest
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- Allenmore Hospital
- Northwest CCOP
- Saint Joseph Medical Center
- Multicare Health System
- Saint Clare Hospital
- PeaceHealth Southwest Medical Center
- Northwest Cancer Specialists
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia University Charleston
- Edwards Comprehensive Cancer Center
- City Hospital
- West Virginia University
- Princeton Community Hospital
- Wheeling Hospital
- Langlade Hospital and Cancer Center
- Fox Valley Hematology and Oncology
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Midelfort Clinic-Clairemont Campus
- Mayo Clinic Health System Eau Claire Hospital - Luther Campus
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- Mercy Health System
- UW Cancer Center Johnson Creek
- Gundersen Lutheran
- Mayo Clinic Health System-Franciscan Healthcare
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Vince Lombardi Cancer Clinic-Marinette
- Marshfield Clinic
- Froedtert and the Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- D N Greenwald Center
- Cancer Center of Western Wisconsin
- Oconomowoc Memorial Hospital-ProHealth Care Inc
- Green Bay Oncology - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Marshfield Clinic at James Beck Cancer Center
- Marshfield Clinic-Rice Lake Center
- Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Clinic Cancer Care at Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic
- Waukesha Memorial Hospital - ProHealth Care
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview Hospital
- Rocky Mountain Oncology
- Welch Cancer Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm 1: Anthracycline-based chemotherapy
Arm 2: docetaxel + cyclophosphamide
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D). Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles. Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses. Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses. Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles