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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002967
• Other study ID #: CDR0000065472
• Secondary ID: NSABP-B-29
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 20, 2013
• Start date: May 1997
• Est. completion date: March 2006

Study information

• Verified date: June 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• octreotide pamoate

• tamoxifen citrate

Locations

Country	Name	City	State
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
United States	Akron City Hospital	Akron	Ohio
United States	Albany Regional Cancer Center	Albany	New York
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Winship Cancer Center	Atlanta	Georgia
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	St. Luke's Network - Bethlehem	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Baptist Medical Center - Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Illinois Masonic Medical Center	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
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	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Michigan State University	East Lansing	Michigan
United States	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Highland Park Hospital	Highland Park	Illinois
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Huntsville Hospital System	Huntsville	Alabama
United States	Community Hospitals of Indianapolis - Regional Cancer Center	Indianapolis	Indiana
United States	Methodist Cancer Center - Indianapolis	Indianapolis	Indiana
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	CCOP - Dayton	Kettering	Ohio
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	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Lucille Parker Markey Cancer Center, University of Kentucky	Lexington	Kentucky
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Norton Healthcare System	Louisville	Kentucky
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	MBCCOP - University of South Alabama	Mobile	Alabama
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Louisiana State University Medical Center - New Orleans	New Orleans	Louisiana
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	West Suburban Hospital Medical Center	Oak Park	Illinois
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Ocala Oncology Center	Ocala	Florida
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Methodist Cancer Center - Omaha	Omaha	Nebraska
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Berkshire Medical Center	Pittsfield	Massachusetts
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
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	Genesee Hospital - Rochester	Rochester	New York
United States	Rockford Clinic	Rockford	Illinois
United States	Sutter Cancer Center	Sacramento	California
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	St. Louis University School of Medicine	Saint Louis	Missouri
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Puget Sound Oncology Consortium	Seattle	Washington
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Central Illinois	Springfield	Illinois
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	CCOP - Northwest	Tacoma	Washington
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	University of Texas Health Center at Tyler	Tyler	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Kent County Memorial Hospital - Rhode Island	Warwick	Rhode Island
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
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	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation