Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002920
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
1999-11-01
Brief Title:
S9630 Medroxyprogesterone in Treating Women With Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Comparison Of Medroxyprogesterone Acetate MA And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen Phase III
Status:
COMPLETED
Status Verified Date:
2012-10
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 It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen
PURPOSE Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ lobular carcinoma in situ Pagets disease of the nipple stage I breast cancer or stage II breast cancer and who are taking tamoxifen
PURPOSE Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ lobular carcinoma in situ Pagets disease of the nipple stage I breast cancer or stage II breast cancer and who are taking tamoxifen
Detailed Description:
OBJECTIVES
Compare endometrial pathologic diagnoses proliferative changes simple or cystic hyperplasia complex adenomatous hyperplasia hyperplasia with atypia and carcinoma in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are randomly assigned to medroxyprogesterone acetate MA vs observation
Compare endometrial pathologic diagnoses persistent endometrial hyperplasia atypia or carcinoma resulting in tamoxifen discontinuation and intermittent bleeding in patients treated with these regimens
Characterize the incidence of spontaneous regression and progression of simple or cystic hyperplasia in these patients
Characterize endometrial biopsy results using different endometrial stripe width cut-off points for cases in which the width is at least 5 mm by endovaginal ultrasound in patients receiving tamoxifen
Compare changes over time in endometrial oncogene expression eg c-fos c-jun p53 IGF1 and receptor status in patients receiving tamoxifen with or without prior chemotherapy who are randomly assigned to MA vs observation
Describe the associations among change in gene expression receptor status endometrial abnormality length of tamoxifen exposure and prior chemotherapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to adjuvant chemotherapy yes vs no number of positive nodes 0-3 vs at least 4 and endovaginal sonogram endometrial stripe less than 5 mm vs at least 5 mm Patients are randomized to 1 of 2 arms
All patients receive adjuvant oral tamoxifen daily for five years
Arm I Patients undergo observation
Arm II Patients receive oral medroxyprogesterone acetate on days 1-14 Treatment repeats every 3 months for 5 years
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 330 patients 165 per arm will be accrued for this study
Compare endometrial pathologic diagnoses proliferative changes simple or cystic hyperplasia complex adenomatous hyperplasia hyperplasia with atypia and carcinoma in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are randomly assigned to medroxyprogesterone acetate MA vs observation
Compare endometrial pathologic diagnoses persistent endometrial hyperplasia atypia or carcinoma resulting in tamoxifen discontinuation and intermittent bleeding in patients treated with these regimens
Characterize the incidence of spontaneous regression and progression of simple or cystic hyperplasia in these patients
Characterize endometrial biopsy results using different endometrial stripe width cut-off points for cases in which the width is at least 5 mm by endovaginal ultrasound in patients receiving tamoxifen
Compare changes over time in endometrial oncogene expression eg c-fos c-jun p53 IGF1 and receptor status in patients receiving tamoxifen with or without prior chemotherapy who are randomly assigned to MA vs observation
Describe the associations among change in gene expression receptor status endometrial abnormality length of tamoxifen exposure and prior chemotherapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to adjuvant chemotherapy yes vs no number of positive nodes 0-3 vs at least 4 and endovaginal sonogram endometrial stripe less than 5 mm vs at least 5 mm Patients are randomized to 1 of 2 arms
All patients receive adjuvant oral tamoxifen daily for five years
Arm I Patients undergo observation
Arm II Patients receive oral medroxyprogesterone acetate on days 1-14 Treatment repeats every 3 months for 5 years
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 330 patients 165 per arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CALGB-49901 | OTHER | None | None |
| S9630 | OTHER | None | None |
| U10CA037429 | NIH | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |