Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003099
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Clinical Trial of N-4-hydroxyphenyl Retinamide 4-HPR and Tamoxifen in Breast Neoplasia Administration During the Period Between the Diagnostic Core Biopsy and Definitive Surgery
Status:
COMPLETED
Status Verified Date:
2012-07
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of fenretinide and tamoxifen before surgery may be an effective way to prevent the recurrence of or further development of breast cancer
PURPOSE Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer
PURPOSE Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of identifying surrogate endpoint biomarkers in women with breast ductal carcinoma in situ and associated neoplastic and preneoplastic lesions II Determine whether treatment with fenretinide and tamoxifen administered daily will cause significant modulation of proposed surrogate endpoint biomarkers in this patient population
OUTLINE This is a randomized placebo controlled study Patients are stratified according to histological diagnosis hyperplasia vs carcinoma All patients undergo a core biopsy and fine needle aspiration of the index lesion and are then assigned randomly to a treatment arm Arm I receives tamoxifen and fenretinide daily Arm II receives a placebo daily Both arms continue for 14-28 days until definitive surgery or a second biopsy is performed
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study 50 patients per arm
OUTLINE This is a randomized placebo controlled study Patients are stratified according to histological diagnosis hyperplasia vs carcinoma All patients undergo a core biopsy and fine needle aspiration of the index lesion and are then assigned randomly to a treatment arm Arm I receives tamoxifen and fenretinide daily Arm II receives a placebo daily Both arms continue for 14-28 days until definitive surgery or a second biopsy is performed
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study 50 patients per arm
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 |
|---|---|---|---|
| CDR0000065829 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-ID-94029 | OTHER | None | None |
| NCI-P97-0113 | None | None | None |