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

Sponsor

Institute of Cancer Research, United Kingdom (Other)

Overall Status

Unknown status

CT.gov ID

NCT00079248

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Hot Flashes Menopausal Symptoms Osteoporosis	Biological: therapeutic progesterone Drug: conjugated estrogens	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)