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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Estrogens; Estrogens, Conjugated (USP); Hormones; Progesterone

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)