Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer
NCT ID: NCT00002967
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1997-05-31
2006-03-31
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and chemotherapy in treating women who have stage I or stage II breast cancer.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are randomized into one of four treatment arms. Arm I: Patients receive oral tamoxifen (TMX) daily continously for 5 years. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm II: Patients receive TMX as in Arm I and octreotide pamoate (SMS 201-995 pa LAR) intramuscularly (IM) every 21 days for 4 doses, followed by octreotide pamoate IM for 28 days for 23 additional doses. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm III: Patients receive doxorubicin (DOX) IV and cyclophosphamide (CTX) IV every 3 weeks for 4 courses and TMX as in Arm I. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy. Arm IV: Patients receive DOX and CTX as in Arm III, TMX as in Arm I, and octreotide pamoate as in Arm II. Patients receive TMX and octreotide pamoate on day 1 of first course of chemotherapy. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy.
PROJECTED ACCRUAL: Total accrual of 3,000 patients will be acrrued for this study over 5 years.
Conditions
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
doxorubicin hydrochloride
octreotide pamoate
tamoxifen citrate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Life expectancy: At least 10 years (excluding diagnosis of cancer) Performance status: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count postoperative at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: Creatinine normal Cardiovascular: No cardiac disease that would preclude the use of doxorubicin (for patients who are to receive adjuvant chemotherapy in this study), including: Myocardial infarction Angina pectoris that requires antianginal medication History of congestive heart failure Arrhythmia associated with concurrent heart failure or cardiac dysfunction Valvular disease with cardiac compromise Cardiomegaly or ventricular hypertrophy unless left ventricular function is within normal limits Poorly controlled hypertension Other: No prior invasive breast cancer or ductal carcimoma in situ No systemic disease that would preclude patients from any part of study No history of symptomatic gallbladder or biliary tract disease unless patient has undergone cholecystectomy No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude No prior nonbreast malignancies in past 10 years except: Squamous or basal cell carcinoma of the skin that has been effectively treated Carcinoma in situ of the cervix that has been treated by operation only Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmented resection only No psychiatric or addictive disorders Not pregnant or nursing Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer No prior anthracycline therapy for patients who are to receive adjuvant chemotherapy in this study Endocrine therapy: No prior endocrine therapy for breast cancer Must discontinue any sex hormonal therapy before prior to and during study Radiotherapy: No prior radiotherapy for breast cancer No breast radiation therapy before randomization for patients who receive lumpectomy Surgery: See Disease Characteristics At least 2 weeks since last surgical procedure Other: No concurrent cyclosporine therapy No concurrent heparin or warfarin anticoagulation therapy
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Principal Investigators
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Richard G. Margolese, MD
Role: STUDY_CHAIR
Jewish General Hospital
Locations
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Baptist Medical Center - Birmingham
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
MBCCOP - University of South Alabama
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Sutter Cancer Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Winship Cancer Center
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Illinois Masonic Medical Center
Chicago, Illinois, United States
Highland Park Hospital
Highland Park, Illinois, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, United States
Rockford Clinic
Rockford, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Methodist Cancer Center - Indianapolis
Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare System
Louisville, Kentucky, United States
Louisiana State University Medical Center - New Orleans
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
New England Medical Center Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic - Burlington
Burlington, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Cancer Center - 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
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States
Albany Regional Cancer Center
Albany, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
Genesee Hospital - Rochester
Rochester, 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
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States
Meridia South Pointe Hospital
Cleveland, Ohio, United States
Mount Sinai Medical Center - Cleveland
Cleveland, 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 Oncology Program
Toledo, Ohio, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Kent County Memorial Hospital - Rhode Island
Warwick, Rhode Island, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Massey Cancer Center
Richmond, 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
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
Countries
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References
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Chapman JA, Costantino JP, Dong B, et al.: Randomized trials of adjuvant tamoxifen versus tamoxifen and octreotide LAR in early-stage breast cancer: NCIC CTG MA.14 and NSABP B-29. [Abstract] J Clin Oncol 30 (Suppl 15): A-538, 2012.
Soran A, Nesbitt L, Mamounas EP, Lembersky B, Bryant J, Anderson S, Brown A, Passarello M. Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Clin Trials. 2006;3(5):478-85. doi: 10.1177/1740774506070747.
Chapman JA, Costantino JP, Dong B, Margolese RG, Pritchard KI, Shepherd LE, Gelmon KA, Wolmark N, Pollak MN. Octreotide LAR and tamoxifen versus tamoxifen in phase III randomize early breast cancer trials: NCIC CTG MA.14 and NSABP B-29. Breast Cancer Res Treat. 2015 Sep;153(2):353-60. doi: 10.1007/s10549-015-3547-4. Epub 2015 Aug 15.
Other Identifiers
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NSABP-B-29
Identifier Type: -
Identifier Source: secondary_id
CDR0000065472
Identifier Type: -
Identifier Source: org_study_id
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