Status:
UNKNOWN
Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
Phase:
NA
Brief Summary
RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer. PURP...
Detailed Description
OBJECTIVES: * Compare disease-free survival and overall survival of postmenopausal women with prior stage I or II breast cancer treated with hormone replacement therapy (HRT) vs nonhormonal alternati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Prior diagnosis of stage I or II breast cancer
- No clinical evidence of recurrence
- Meets criteria for 1 of the following:
- Amenorrheic for at least the past 6 months
- Radiotherapy- or chemically-induced ovarian suppression allowed
- Prior surgical bilateral oophorectomy
- Experiencing vasomotor symptoms (i.e., hot flashes or night sweats) with or without vaginal dryness
- No undiagnosed postmenopausal bleeding
- No ductal carcinoma in situ or lobular carcinoma in situ alone
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- Postmenopausal
- Sex
- Female
- Menopausal status
- Postmenopausal
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- No severe, active liver disease with abnormal liver function tests
- No acute, intermittent porphyria
- Fibrinolysis and coagulation normal
- Renal
- Not specified
- Cardiovascular
- No prior deep vein thrombosis
- Thrombophlebitis or superficial phlebitis alone allowed
- No prior retinal vein thrombosis
- Pulmonary
- No prior pulmonary embolism
- Other
- Not pregnant
- No prior alcohol, drug, or chemical abuse
- No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- More than 3 months since prior oral or transdermal hormone replacement therapy (HRT)
- More than 5 years since prior HRT implant
- No other concurrent HRT
- No concurrent gonadotropin-releasing hormone agonists (e.g., goserelin) if less than 2 years of planned treatment remains
- No other concurrent low-dose progestins
- No concurrent tibolone
- No concurrent phytoestrogens (e.g., black cohosh, red clover, or soy)
- Radiotherapy
- See Disease Characteristics
- Surgery
- See Disease Characteristics
- Other
- No concurrent Hypericum perforatum (St. John's wort)
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079248
Start Date
March 1 2002
Last Update
May 12 2009
Active Locations (1)
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1
Institute of Cancer Research - UK
Sutton, England, United Kingdom, SM2 5NG