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Randomized Study of Hormone Replacement Therapy for Relieving Menopausal Symptoms in Postmenopausal Women With Prior Stage I or II Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Supportive care | Closed | Postmenopausal | CRUK-HRT
EU-20112, ISRCTN29941643, NCT00079248 |
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 alternatives to HRT.
- Compare relief of menopausal symptoms and quality of life of patients treated with these regimens.
- Compare cardiovascular and osteoporotic events in patients treated with these regimens.
Entry Criteria 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:
Prior/Concurrent Therapy:
Biologic therapy 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
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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)
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic - No severe, active liver disease with abnormal liver function tests
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No acute, intermittent porphyria
- Fibrinolysis and coagulation normal
Renal 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
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No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
Expected Enrollment A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study. Outline This is a randomized, multicenter study. Patients are stratified according to participating center, age (< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs > 2 to < 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without progesterone for at least 2 years.
- Arm II: Patients are offered advice on nonhormonal HRT alternatives.
Menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter. Patients are followed every 6 months for 3 years and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK
Trial Contact Information
Trial Lead Organizations Institute of Cancer Research - Sutton | | | | Jenni Parmar, RN, Study coordinator | | | |
| Registry Information | | | Official Title | | UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer | | | Trial Start Date | | 2002-03-01 | | | Registered in ClinicalTrials.gov | | NCT00079248 | | | Date Submitted to PDQ | | 2004-01-28 | | | Information Last Verified | | 2005-06-16 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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