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.

PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage I or stage II breast cancer.

Condition	Treatment or Intervention
Osteoporosis stage I breast cancer stage II breast cancer menopausal symptoms Hot Flashes	Drug: conjugated estrogens  Drug: progesterone  Procedure: complications of therapy assessment/management  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: supportive care/therapy

Further Study Details: 

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.

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.

PROJECTED ACCRUAL: A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study.

Genders Eligible for Study:  Both

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:
• 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)

United Kingdom, England
      Institute of Cancer Research - UK, Sutton,  England,  SM2 5NG,  United Kingdom; Recruiting

Study chairs or principal investigators

Judith Bliss,  National Cancer Research Institute (NCRI)   

Study ID Numbers:  CDR0000355122; CRUK-HRT; EU-20112; ISRCTN-29941643; NCT00079248
Record last reviewed:  February 2004
Last Updated:  March 10, 2005
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079248
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08