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Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002967
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: octreotide pamoate
Drug: tamoxifen citrate
Phase III

Study Type: Interventional
Study Design: Treatment
Official Title: A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1997
Detailed Description:

OBJECTIVES: I. Determine whether the addition of octreotide pamoate to tamoxifen alone or to tamoxifen and chemotherapy improves the disease free survival of patients with primary invasive breast cancer with estrogen receptor (ER) positive tumors and histologically negative axillary lymph nodes or histologically negative sentinel lymph nodes if participating in NSABP B-32. II. Determine whether the rate of endometrial cancer associated with tamoxifen is altered by the concurrent administration of octreotide pamoate. III. Determine whether the addition of octreotide pamoate to tamoxifen decreases the rate of opposite breast cancer more than tamoxifen alone. IV. Evaluate the incidence of gallstone formation (including the development of symptoms and complications of biliary tract disease), hyper and hypoglycemia, hypothyroidism, and vitamin B12 deficiency in patients treated with octreotide pamoate in comparison with patients not treated with octreotide pamoate.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed Stage I, IIA or IIB invasive adenocarcinoma of the breast with T1-3, pN0 and M0 classification Must have undergone total mastectomy or lumpectomy followed by an axillary dissection or sentinel node resection if participating in NSABP B-32 Histologically negative axillary lymph nodes OR Histologically negative sentinel lymph nodes if participating in NSABP B-32 Lumpectomy and axillary dissection acceptable only if margins of resected specimen are histologically free of invasive tumor or ductal carcinoma in situ and other dominant masses within the ipsilateral breast remnant are histologically confirmed to be benign Additional operation after resection is allowed in order to obtain clear margins No bilateral malignancy of the breast ER positive tumors as defined by at least one of the following: At least 10 fmol/mg cytosol protein by either dextran-coated charcoal or sucrose density gradient methods Positive or not definitely negative results by the enzyme immunoassay method (EIA) or by immunocytochemical assay No more than 63 days from time of initial cytologic or histologic diagnosis of breast cancer till randomization No bone metastases (confirmation must be made for those with skeletal pain) Tumor must be no greater than 5 cm in its greatest dimension for patients who are treated by lumpectomy and axillary dissection Hormone receptor status: Estrogen receptor positive

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002967

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center - Birmingham
Birmingham, Alabama, United States, 35213
Huntsville Hospital System
Huntsville, Alabama, United States, 35801
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, United States, 92037
Sutter Cancer Center
Sacramento, California, United States, 95816
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Ocala Oncology Center
Ocala, Florida, United States, 34474
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Winship Cancer Center
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Springfield, Illinois, United States, 62526
Rockford Clinic
Rockford, Illinois, United States, 61103
Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Highland Park Hospital
Highland Park, Illinois, United States, 60035-2497
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
West Suburban Hospital Medical Center
Oak Park, Illinois, United States, 60302
United States, Indiana
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States, 46219
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Methodist Cancer Center - Indianapolis
Indianapolis, Indiana, United States, 46206-1367
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Norton Healthcare System
Louisville, Kentucky, United States, 40202-5070
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University School of Medicine
Saint Louis, Missouri, United States, 63104
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13210
Genesee Hospital - Rochester
Rochester, New York, United States, 14607
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Columbus
Columbus, Ohio, United States, 43206
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States, 45236
Meridia South Pointe Hospital
Cleveland, Ohio, United States, 44122
Mount Sinai Medical Center - Cleveland
Cleveland, Ohio, United States, 44122
United States, Oklahoma
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States, 18015
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
York Hospital
York, Pennsylvania, United States, 17315
United States, Rhode Island
Kent County Memorial Hospital - Rhode Island
Warwick, Rhode Island, United States, 02886
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
United States, Texas
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75710
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
United States, West Virginia
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Study Chair: Richard G. Margolese, MD Jewish General Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000065472, NSABP-B-29
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002967     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
invasive ductal breast carcinoma

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Octreotide
Bone Density Conservation Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Breast Diseases
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Breast Neoplasms
Immunosuppressive Agents
Tamoxifen
Pharmacologic Actions
Doxorubicin
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 25, 2009