Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00079248|
Recruitment Status : Unknown
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 10, 2004
Last Update Posted : May 12, 2009
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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|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 :||March 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079248
|Institute of Cancer Research - UK|
|Sutton, England, United Kingdom, SM2 5NG|
|OverallOfficial:||Jenni Parmar, RN||Institute of Cancer Research, United Kingdom|