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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|