Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079248
Status:
UNKNOWN
Last Update Posted:
2009-05-12
First Post:
2004-03-08
Brief Title:
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
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
UK Trial Of Hormone Replacement Therapy HRT In Women With A History Of Early Stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 2800-3000 patients 1400-1500 per treatment arm will be accrued for this study
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 2800-3000 patients 1400-1500 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRUK-HRT | None | None | None |
| EU-20112 | None | None | None |
| ISRCTN29941643 | None | None | None |