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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 22 Locations for this study
Birmingham Alabama, 35294, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Wichita Kansas, 67214, United States
Ann Arbor Michigan, 48106, United States
Kalamazoo Michigan, 49007, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68131, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10461, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57104, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Madison Wisconsin, 53705, United States
Madison Wisconsin, 53792, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.