Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002646
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
1999-11-01
Brief Title:
Hormone Therapy in Treating Postmenopausal Women With Receptor-Positive Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III DOUBLE-BLIND PLACEBO-CONTROLLED PROSPECTIVE RANDOMIZED COMPARISON OF ADJUVANT THERAPY WITH TAMOXIFEN VS TAMOXIFEN AND FENRETINIDE IN POSTMENOPAUSAL WOMEN WITH INVOLVED AXILLARY LYMPH NODES AND POSITIVE RECEPTORS
Status:
COMPLETED
Status Verified Date:
2010-10
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 Estrogen can stimulate the growth of breast cancer cells Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen Combining chemotherapy with hormone therapy may kill more tumor cells Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of fenretinide may be an effective way to prevent the recurrence of breast cancer It is not yet known whether tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive andor progesterone receptor positive
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive andor progesterone receptor positive
Detailed Description:
OBJECTIVES I Compare disease free survival and overall survival of postmenopausal women with stage II or IIIA breast cancer treated with tamoxifen TMX and fenretinide HPR vs TMX and placebo II Gain wider experience in the use and toxicity of combined TMXHPR in these patients III Obtain tumor tissue samples as feasible from these patients for future biologic studies
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified by participating institution age under 70 vs 70 and over node dissection yes vs no number of involved nodes 0 vs 1-3 vs 4 or more and number of removed nodes 1-5 vs 6 or more All patients receive oral tamoxifen daily for at least 5 years beginning immediately after randomization Patients also receive either oral fenretinide or oral placebo daily for 5 years beginning within 2 weeks after completion of any radiotherapy or within 2 weeks of randomization if no radiation Patients are followed during and after treatment every 4 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study over approximately 3 years
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified by participating institution age under 70 vs 70 and over node dissection yes vs no number of involved nodes 0 vs 1-3 vs 4 or more and number of removed nodes 1-5 vs 6 or more All patients receive oral tamoxifen daily for at least 5 years beginning immediately after randomization Patients also receive either oral fenretinide or oral placebo daily for 5 years beginning within 2 weeks after completion of any radiotherapy or within 2 weeks of randomization if no radiation Patients are followed during and after treatment every 4 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study over approximately 3 years
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 |
|---|---|---|---|
| INT-0151 | None | None | None |
| E-EB193 | None | None | None |
| CLB-9443 | None | None | None |
| NCCTG-953052 | None | None | None |
| SWOG-9514 | None | None | None |