Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer
NCT ID: NCT00003099
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
1996-05-31
2003-01-31
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1 Tamoxifen + Fenretinide
Tamoxifen + Fenretinide daily for 14-28 days
Fenretinide
Daily for 14-28 days.
Tamoxifen Citrate
Daily for 14-28 days.
Arm 2 Placebo
Placebo daily for 14-28 days
Placebo
Daily for 14-28 days
Interventions
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Fenretinide
Daily for 14-28 days.
Tamoxifen Citrate
Daily for 14-28 days.
Placebo
Daily for 14-28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled congestive heart failure Other: Fasting serum triglycerides less than 400 mg/dL Fertile patients must use effective contraception during and for one year after completing fenretinide therapy No concurrent serious illness or infection, e.g., septicemia No prior thromboembolic disease No prior degenerative retinal disease
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: At least 12 months since prior tamoxifen therapy No concurrent estrogen therapy At least 3 months since prior anabolic steroids Radiotherapy: No prior radiotherapy to the chest or breast Surgery: See Disease Characteristics Other: No vitamin A supplementation greater than 25,000 IU At least 12 months since prior retinoid therapy
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sonja E. Singletary, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-94029
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P97-0113
Identifier Type: -
Identifier Source: secondary_id
CDR0000065829
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID94-029
Identifier Type: -
Identifier Source: org_study_id