UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
N/A
N/A
Female
Breast Cancer, Hot Flashes, Menopausal Symptoms, Osteoporosis
Trial Information
UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Jenni Parmar, RN
Investigator Affiliation:
Institute of Cancer Research, United Kingdom
Authority:
United States: Federal Government
Study ID:
CDR0000355122
NCT ID:
NCT00079248
Start Date:
March 2002
Completion Date:
Related Keywords:
- Breast Cancer
- Hot Flashes
- Menopausal Symptoms
- Osteoporosis
- osteoporosis
- stage I breast cancer
- stage II breast cancer
- menopausal symptoms
- hot flashes
- Breast Neoplasms
- Osteoporosis
- Hot Flashes
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