Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001378
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Trial of Tamoxifen and 4-HPR 4-N-Hydroxyphenyl Retinamide in Persons at High Risk for Developing Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Trial of Tamoxifen and 4-HPR 4-N-Hydroxyphenyl Retinamide in Persons at High Risk for Developing Breast Cancer
Status:
COMPLETED
Status Verified Date:
1999-11
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:
This is a pilot chemoprevention study Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months beginning the second month of fenretinide
Patients are removed from study for unacceptable toxicity the development of invasive breast cancer or for dysfunctional uterine bleeding
Patients are removed from study for unacceptable toxicity the development of invasive breast cancer or for dysfunctional uterine bleeding
Detailed Description:
This is a pilot chemo-prevention study of the combination tamoxifen and 4-HPR in persons at increased risk of developing invasive breast cancer The objectives of the study are to determine the acute and cumulative toxicity of tamoxifen and 4-HPR in high risk persons to assess the feasibility of obtaining adequate tissue to study potential intermediate biomarkers of proliferative disease and malignancy using nipple aspiration four quadrant fine needle aspirates and breast core needle biopsies and to study the effects of tamoxifen and 4-HPR on TGF-beta isoforms and the proliferative markers ki67 and PCNA pre- and post-therapy
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 |
|---|---|---|---|
| 94-C-0056 | None | None | None |