Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Hot Flashes; Menopausal Symptoms; Osteoporosis
Intervention: conjugated estrogens (Drug); therapeutic progesterone (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Institute of Cancer Research, United Kingdom Official(s) and/or principal investigator(s):
Jenni Parmar, RN, Affiliation: Institute of Cancer Research, United Kingdom
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 Details
Official title: UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Study design: Supportive Care, Randomized, Active Control
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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)
Locations and Contacts
Institute of Cancer Research - UK, Sutton, England SM2 5NG, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2002
Last updated: May 23, 2008
|
