A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
OBJECTIVES:
- Determine the efficacy of hormone replacement therapy in managing hot flashes and
menopausal vaginal symptoms in postmenopausal women with a history of node-negative
invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant
tamoxifen.
- Determine the effect of this regimen on blood coagulation and lipid profiles in these
patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs
vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or
more), and average daily number of hot flashes (less than 10 or none vs 10 or more).
Patients are randomized to one of two treatment arms.
- Arm I: Patients who have not undergone prior hysterectomy receive oral
medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not
resolve, patients receive oral conjugated estrogens once daily in addition to
medroxyprogesterone for 5 months. Patients who have undergone prior hysterectomy
receive oral conjugated estrogens once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is
assessed at baseline and months 1, 2, 3, and 6.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study within 12 months.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Melody A. Cobleigh, MD
Study Chair
Rush University Medical Center
United States: Federal Government
CDR0000069015
NCT00026286
September 2000
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |