Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

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.

Further Study Information

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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

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

Eligibility 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Institute of Cancer Research - Sutton

Jenni Parmar

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00079248
Information obtained from ClinicalTrials.gov on December 14, 2011

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