Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer

Not Applicable

• Conditions: Breast Cancer; Hot Flashes; Menopausal Symptoms; Osteoporosis

• Registration Number: NCT00079248
• Lead Sponsor: Institute of Cancer Research, United Kingdom

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.

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.

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 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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2004-03-08
• Study First Submitted QC: 2004-03-09
• Study First Posted: 2004-03-10
• Status Verified: 2005-06
• Last Update Submitted: 2009-05-09
• Last Update Posted: 2009-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Institute of Cancer Research - UK; 🇬🇧 Sutton, England, United Kingdom