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

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: conjugated estrogens
• Drug: therapeutic progesterone

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Institute of Cancer Research, United Kingdom

Overall Clinical Trial Officials and Contacts

Jenni Parmar, RN  Institute of Cancer Research, United Kingdom  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00079248

Study ID Number: CDR0000355122

ClinicalTrials.gov Identifier: NCT00079248

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database