Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003771
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
Sponsor:
Regional Oncologic Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy HRT After Previous Radical Breast Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2001-07
Last Known Status:
None
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 is effective for relieving symptoms of menopause It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer
PURPOSE Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms
PURPOSE Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms
Detailed Description:
OBJECTIVES
Evaluate the safety of hormone replacement therapy in terms of risk of recurrence in women with previously treated nonrecurrent stage 0-II breast cancer
Compare this regimen vs non-hormonal symptomatic treatment in terms of quality of life and risk of death in this patient population
OUTLINE This is a randomized open-label multicenter study Patients are stratified by center prior hormone replacement therapy before diagnosis and concurrent tamoxifen therapy Patients are randomized to one of two treatment arms
Arm I Patients receive one of the following Women with an intact uterus whose last menstrual bleeding has occurred within 2 years receive continuous oral cyclic estradiol-norethindrone combination comprising estradiol only on days 1-12 estradiol plus norethindrone on days 13-22 and then estradiol only on days 22-28 Women with an intact uterus whose last menstrual bleeding occurred more than 2 years prior to study receive continuous daily oral estradiol-norethindrone combination Women who have had a hysterectomy receive continuous daily oral estradiol only
Arm II Patients receive one or more non-hormonal therapies eg clonidine beta blockers psychological support physical exercise acupuncture
Treatment in both arms continues for 2 years in the absence of disease progression Patients may continue their randomized treatment regimen at the discretion of the treating physician
Quality of life is assessed 3 times during the study and then every two years thereafter Gynecological health is assessed at 3 months 6 months and one year during the study and then annually for at least 5 years Breast cancer is assessed every 6 months for 3 years and then annually thereafter or at the discretion of the treating physician
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study within 5-6 years
Evaluate the safety of hormone replacement therapy in terms of risk of recurrence in women with previously treated nonrecurrent stage 0-II breast cancer
Compare this regimen vs non-hormonal symptomatic treatment in terms of quality of life and risk of death in this patient population
OUTLINE This is a randomized open-label multicenter study Patients are stratified by center prior hormone replacement therapy before diagnosis and concurrent tamoxifen therapy Patients are randomized to one of two treatment arms
Arm I Patients receive one of the following Women with an intact uterus whose last menstrual bleeding has occurred within 2 years receive continuous oral cyclic estradiol-norethindrone combination comprising estradiol only on days 1-12 estradiol plus norethindrone on days 13-22 and then estradiol only on days 22-28 Women with an intact uterus whose last menstrual bleeding occurred more than 2 years prior to study receive continuous daily oral estradiol-norethindrone combination Women who have had a hysterectomy receive continuous daily oral estradiol only
Arm II Patients receive one or more non-hormonal therapies eg clonidine beta blockers psychological support physical exercise acupuncture
Treatment in both arms continues for 2 years in the absence of disease progression Patients may continue their randomized treatment regimen at the discretion of the treating physician
Quality of life is assessed 3 times during the study and then every two years thereafter Gynecological health is assessed at 3 months 6 months and one year during the study and then annually for at least 5 years Breast cancer is assessed every 6 months for 3 years and then annually thereafter or at the discretion of the treating physician
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study within 5-6 years
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 |
|---|---|---|---|
| EU-98077 | None | None | None |
| ROC-HABITS | None | None | None |
| EORTC-10992 | None | None | None |
| IBCSG-17-98 | None | None | None |
| SBG-HABITS | None | None | None |