Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast
No contralateral breast cancer
No recurrent or metastatic disease
Completion of active non-hormonal therapy for breast cancer
Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study
Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR
Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency
If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year
No active endometriosis
No unexplained vaginal bleeding

Hormone receptor status:

Estrogen and progesterone receptor status known for patients with invasive breast cancer

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Postmenopausal
No menstrual period for more than 12 months OR prior bilateral oophorectomy
Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Cardiovascular:

No prior superficial or deep venous or arterial thrombosis
No serious venous stasis disease

Pulmonary:

No pulmonary embolus

Other:

Must be able to read and speak English
No lower extremity trauma, swelling, or tenderness within the past 4 weeks
No active gallbladder disease
No migraine headaches
No other prior malignancy unless curatively treated with no evidence of recurrence
No concurrent seizure disorder requiring anti-seizure medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

See Disease Characteristics
No other concurrent estrogen or hormone replacement therapy
No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes
No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only

Radiotherapy:

Not specified

Surgery:

At least 4 weeks since prior surgery

Other:

At least 12 months since prior treatment for congestive heart failure
Concurrent selective serotonin reuptake inhibitors (SSRI) or antidepressants with SSRI activity allowed if begun at least 3 months prior to study and continue during study

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00026286

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 22 Locations for this study

See Locations Near You

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00026286

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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