S9630, Medroxyprogesterone in Treating Women With Breast Cancer
Breast Cancer, Endometrial Cancer
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring endometrial cancer, stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, lobular breast carcinoma in situ, Paget disease of the breast
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following histologically proven diagnoses: Primary invasive adenocarcinoma of the unilateral or bilateral breast Stage I, IIA, or IIB (T1-3, N0-1, M0) No recurrent invasive breast cancer Ductal carcinoma in situ (DCIS) Lobular carcinoma in situ (LCIS) with microinvasion Paget's disease of the nipple No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast Currently free of breast cancer (no evidence of disease) No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy Surgical margins clear of both infiltrating carcinoma (any type) and DCIS No gross or microscopically positive margins except: Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy Gross or LCIS at the final margin Biopsy requirement waived for DCIS or LCIS with minimal microinvasion Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma Patients must be planning one of the following: Starting adjuvant tamoxifen for five years OR Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years Hormone receptor status: Candidate for adjuvant tamoxifen therapy PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Postmenopausal defined as: At least 1 year since last menstrual period At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis 4-12 months since last menstrual period and FSH elevated to postmenopausal range Postmenopausal estrogen therapy and 55 years of age or older Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fertile patients must use effective contraception during and for at least 2 months after study No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission No concurrent nonmalignant-related illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Adjuvant chemotherapy allowed No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No prior hormonal treatment for breast cancer (except tamoxifen) No concurrent postmenopausal estrogen therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics No prior or concurrent hysterectomy Other: No prior or current participation in an adjuvant intergroup trial
Sites / Locations
- MBCCOP - Gulf Coast
- Providence Alaska Medical Center
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Veterans Affairs Medical Center - Loma Linda (Pettis)
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- Naval Medical Center - San Diego
- CCOP - Santa Rosa Memorial Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- MBCCOP - Howard University Cancer Center
- Broward General Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Greenebaum Cancer Center at University of Maryland Medical Center
- Cancer Research Center at Boston Medical Center
- UMASS Memorial Cancer Center - University Campus
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Health System
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital - Southfield
- University of Minnesota Cancer Center
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital
- St. Louis University Hospital Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- New Hampshire Oncology-Hematology, PA - Hooksett
- Cooper University Hospital
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- North Shore University Hospital
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Mount Sinai Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Asheville
- NorthEast Oncology Associates - Concord
- CCOP - Southeast Cancer Control Consortium
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- Comprehensive Cancer Center at Wake Forest University
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital at Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Veterans Affairs Medical Center - Memphis
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Vermont Cancer Center at University of Vermont
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Tamoxifen alone
Tamoxifen plus MPA
Tamoxifen alone x 5 years
Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years