Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
NCT ID: NCT00003782
Last Updated: 2024-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5351 participants
INTERVENTIONAL
1999-03-31
2012-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.
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Detailed Description
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* Compare the efficacy of adjuvant doxorubicin, cyclophosphamide, and docetaxel given concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel, in terms of overall survival and disease-free survival, of women with breast cancer and positive axillary lymph nodes.
* Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing cyclophosphamide in these patients.
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens. (Quality of life substudy closed to accrual as of 7/20/01.)
* Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms, quality of life (quality of life substudy closed to accrual as of 7/20/01), disease-free survival, and overall survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive nodes (1-3 vs 4-9 vs at least 10), sequential tamoxifen or anastrozole administration (yes vs no), and type of prior surgery and radiotherapy plan (mastectomy with no local or regional radiotherapy vs mastectomy with local and/or regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with local and regional radiotherapy). Patients are randomized to one of three treatment arms.
* Arm 1: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes every 21 days for 4 courses. Three weeks after the last dose of this combination, patients receive docetaxel IV over 1 hour every 21 days for 4 courses.
* Arm 2: Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour every 21 days for 4 courses.
* Arm 3: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30 minutes, and docetaxel IV over 1 hour every 21 days for 4 courses.
Patients in all arms who are estrogen receptor-positive and/or progesterone receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of completion of chemotherapy. Patients who are postmenopausal may receive alternative hormonal therapy at the discretion of the treating physician.
Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA.20 after recovery from chemotherapy.
Quality of life and menstrual history are assessed before randomization, on day 1 of course 4, and at 6, 12, 18, and 24 months. (Quality of life substudy closed to accrual as of 7/20/01.)
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within 4-5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel
Doxorubicin + Cyclophosphamide, then Docetaxel
cyclophosphamide
Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
docetaxel
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
doxorubicin
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Arm 2: Doxorubicin + Docetaxel
Doxorubicin + Docetaxel
docetaxel
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
doxorubicin
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Doxorubicin + Docetaxel + Cyclophosphamide
cyclophosphamide
Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
docetaxel
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
doxorubicin
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Interventions
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cyclophosphamide
Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
docetaxel
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
doxorubicin
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Bilirubin no greater than ULN
* Alkaline phosphatase less than 2.5 times ULN\*
* SGOT less than 1.5 times ULN\*
* No nonmalignant systemic hepatic disease that would preclude study participation NOTE: \*Alkaline phosphatase and SGOT cannot both be greater than ULN
Renal:
* Creatinine no greater than normal
* No nonmalignant systemic renal disease that would preclude study participation
Cardiovascular:
* No nonmalignant systemic cardiovascular disease that would preclude study participation
* LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram
* No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:
* Any prior myocardial infarction
* Angina pectoris requiring anti-anginal medication
* History of congestive heart failure
* Cardiac arrhythmia requiring medication
* Severe conduction abnormality
* Valvular disease with documented cardiac function compromise
* Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN
* Poorly controlled hypertension (diastolic greater than 100 mm/Hg)
* Hypertension well controlled by medication allowed
Other:
* No grade 2 or greater peripheral neuropathy
* No other prior malignancy within the past 5 years except:
* Effectively treated squamous cell or basal cell skin cancer
* Surgically treated carcinoma in situ of the cervix
* Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No nonmalignant systemic disease that would preclude study participation
* No diabetes with morning fasting blood glucose of 200 mg/dL or greater
* No psychiatric or addictive disorders that would preclude informed consent
* No contraindication to corticosteroids that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for breast cancer
Chemotherapy:
* No prior chemotherapy for breast cancer
* No prior anthracyclines or taxanes
* No other concurrent investigational chemotherapy
Endocrine therapy:
* No prior hormonal therapy for breast cancer
* No concurrent hormonal birth control methods or other hormonal therapy
* No concurrent raloxifene, including for osteoporosis
* Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy for this malignancy
Surgery:
* See Disease Characteristics
* No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins)
Other:
* No prior systemic therapy for this malignancy
* No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons \[e.g., hypertension\])
* Concurrent bisphosphonates allowed
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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Comprehensive Cancer Institute
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Stanford Cancer Center at Stanford University Medical Center
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Catholic Healthcare West - Westbay Region
San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
University of Connecticut Cancer Center at University of Connecticut Health Center
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Community Hospital
Munster, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Norton Healthcare Cancer Center
Louisville, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
National Naval Medical Center
Bethesda, Maryland, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, United States
Charles R. Wood Foundation Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
Alamance Cancer Center
Burlington, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Akron City Hospital
Akron, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Jewish Hospital of Cincinnati, Incorporated
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
South Pointe Hospital - Cancer Care Center
Warrensville Heights, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Wellspan Health - York Cancer Center
York, Pennsylvania, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Puget Sound Oncology Consortium
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
Countries
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References
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Swain SM, Land SR, Ritter MW, Costantino JP, Cecchini RS, Mamounas EP, Wolmark N, Ganz PA. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat. 2009 Jan;113(2):315-20. doi: 10.1007/s10549-008-9937-0. Epub 2008 Feb 27.
Ganz PA, Land SR, Geyer CE, et al.: NSABP B-30: definitive analysis of quality of life (QOL) and menstrual history (MH) outcomes from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-76, 2008.
Swain SM, Jeong JH, Geyer CE, et al.: NSABP B-30: definitive analysis of patient outcome from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-75, 2008.
Swain SM, Land SR, Sundry R, et al.: Amenorrhea in premenopausal women on the doxorubicin (A) and cyclophosphamide (C) followed-by docetaxel (T) arm of NSABP B-30: preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-537, 13s, 2005.
Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA. Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162.
Swain SM, Jeong JH, Geyer CE Jr, Costantino JP, Pajon ER, Fehrenbacher L, Atkins JN, Polikoff J, Vogel VG, Erban JK, Rastogi P, Livingston RB, Perez EA, Mamounas EP, Land SR, Ganz PA, Wolmark N. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010 Jun 3;362(22):2053-65. doi: 10.1056/NEJMoa0909638.
Other Identifiers
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CDR0000066914
Identifier Type: -
Identifier Source: secondary_id
NSABP B-30
Identifier Type: -
Identifier Source: org_study_id
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