Overview

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)