Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Hot Flashes; Menopausal Symptoms
Intervention: conjugated estrogens (Drug); medroxyprogesterone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eastern Cooperative Oncology Group Official(s) and/or principal investigator(s):
Melody A. Cobleigh, MD, Study Chair, Affiliation: Rush University Medical Center
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.
Clinical Details
Official title: 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
Study design: Supportive Care, Randomized, Double-Blind, Active Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611-3013, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611, United States
Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana 46202, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, 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 44106-5065, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104-4283, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee 37212, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin 53705, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2000
Last updated: May 23, 2008
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