Spots Global Cancer Trial Database for Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer
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Trial Identification
Brief Title: Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer
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
Study ID: NCT00002967
Conditions
Study Description
Brief 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.
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
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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 AFB, Mississippi, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University School of Medicine, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint 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
Contact Details
Name: Richard G. Margolese, MD
Affiliation: Jewish General Hospital
Role: STUDY_CHAIR
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