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

Breast Cancer Clinical Trial

Official title: UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes
• Menopausal Symptoms
• Osteoporosis

• NCT number: NCT00079248
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2002