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

NCT00003782 | Completed Phase 3 Results DMC

• 2 other identifiers: NSABP B-30CDR0000066914
• Study Type: interventional
• Target: 5,351
• Locations: 2 countries
• Sites: 157

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes. 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  8 years

• Disease Free Survival

  time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event

Secondary Outcomes (3)

• Toxicities Among the 3 Regimens

  9 years

• Quality of Life Among Breast Cancer Patients

  baseline, 9 weeks, and 6, 12, 18, and 24 months

• Amenorrhea in Premenopausal Women

  baseline, 9 weeks, and 6, 12, 18, and 24 months

Study Arms (3)

Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel

EXPERIMENTAL

Doxorubicin + Cyclophosphamide, then Docetaxel

Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin

Arm 2: Doxorubicin + Docetaxel

EXPERIMENTAL

Doxorubicin + Docetaxel

Drug: docetaxel; Drug: doxorubicin

Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide

EXPERIMENTAL

Doxorubicin + Docetaxel + Cyclophosphamide

Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin

Interventions

cyclophosphamide DRUG

Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles

Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel; Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide

docetaxel DRUG

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

Also known as: Taxotere

Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel; Arm 2: Doxorubicin + Docetaxel; Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide

doxorubicin DRUG

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

Also known as: Adriamycin

Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel; Arm 2: Doxorubicin + Docetaxel; Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the breast * Confined to the breast and ipsilateral axilla on clinical exam * Stage I, II, or IIIA (cT1-3, N0-1, M0) * At least one axillary lymph node with evidence of tumor on histologic exam * Sentinel node biopsy allowed if followed by axillary dissection * No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor * No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign * Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR * Prior lumpectomy and axillary dissection * Patients must receive radiotherapy after randomization (not before) AND after chemotherapy * Margins must be clear * No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes) * No histologically evident invasive tumor or ductal carcinoma in situ * No diffuse tumors by mammography that would not be surgically amenable to lumpectomy * No other dominant mass in the ipsilateral breast remnant unless one of the following is true: * Histologically benign * Surgically removed with clear margins if malignant * No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude * Tethering or dimpling of the skin or nipple inversion allowed * No metastatic disease * Skeletal pain allowed if bone scan negative for metastases * Hormone receptor status: * Estrogen and progesterone status determined PATIENT CHARACTERISTICS: Age: * greater than or equal to 18 years Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * At least 10 years, excluding diagnosis of cancer Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation) * Platelet count at least 100,000/mm\^3\* NOTE: \*If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded Hepatic: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (157)

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99519-6604, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

California Cancer Center

Fresno, California, 93720, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Scripps Cancer Center at Scripps Clinic

La Jolla, California, 92037, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Palo Alto, California, 94305-5408, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Catholic Healthcare West - Westbay Region

San Francisco, California, 94107-1728, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80209-5031, United States

Location

University of Connecticut Cancer Center at University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Medical College of Georgia Comprehensive Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-9985, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46206-1367, United States

Location

St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Genesis Medical Center

Davenport, Iowa, 52804, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0093, United States

Location

Norton Healthcare Cancer Center

Louisville, Kentucky, 40202-5070, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889-5000, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

Providence Cancer Institute at Providence Hospital

Southfield, Michigan, 48075-9975, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

New York Oncology Hematology, P.C. - Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

Charles R. Wood Foundation Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

Alamance Cancer Center

Burlington, North Carolina, 27216, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

Greenville, North Carolina, 27858-4354, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Jewish Hospital of Cincinnati, Incorporated

Cincinnati, Ohio, 45236, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

South Pointe Hospital - Cancer Care Center

Warrensville Heights, Ohio, 44122, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97213, United States

Location

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Wellspan Health - York Cancer Center

York, Pennsylvania, 17315, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis

Memphis, Tennessee, 38146, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Virginia Oncology Associates - Newport News

Newport News, Virginia, 23606, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304-1297, United States

Location

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Hopital du Saint-Sacrement, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Related Publications (6)

• 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.

  PMID: 18302020 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 28954297 DERIVED

• 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.

  PMID: 20519679 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Director, Division of Regulatory Affairs
• Organization: NSABP Foundation, Inc.

412-330-4600

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1999
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2012
• Last Updated: March 21, 2024
• Results First Posted: October 31, 2012

Record last verified: 2024-03

Locations

CA (11); US (146)