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
- 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
- Determine the effect of this regimen on blood coagulation and lipid profiles in these
- 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
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study within 12 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Melody A. Cobleigh, MD
Rush University Medical Center
United States: Federal Government
|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|