Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer

June 20, 2013 updated by: NSABP Foundation Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Richard G. Margolese, MD, Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 2, 2004

First Posted (ESTIMATE)

September 3, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065472
  • NSABP-B-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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