Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer
NCT00003099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2012-07-30
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.
Conditions
Interventions
- DRUG
-
Fenretinide
Daily for 14-28 days.
- DRUG
-
Tamoxifen Citrate
Daily for 14-28 days.
- OTHER
-
Placebo
Daily for 14-28 days
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Sonja E. Singletary, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1996-05-31
- Primary Completion
- 2000-06-30
- Completion
- 2003-01-31
Countries
- United States
Study Locations
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