Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Phase 3

Completed

• Conditions: Hot Flashes; Breast Cancer; Menopausal Symptoms

• Registration Number: NCT00026286
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.

Detailed Description

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.

Study Timeline

• Study Start: 2000-11-28
• Study First Submitted: 2001-11-09
• Primary Completion: 2002-08
• Study First Submitted QC: 2003-09-16
• Study First Posted: 2003-09-17
• Study Completion: 2007-06-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago; 🇺🇸 Chicago, Illinois, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush); 🇺🇸 Indianapolis, Indiana, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Ann Arbor Regional; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

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