- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003099
Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Mammogram highly suspicious for ductal carcinoma in situ or early invasive carcinoma Branching or linear microcalcifications clustered or distributed segmentally in the breast without an associated palpable or mammographic mass Palpable thickening or nipple discharge allowed At least 5 mm area of calcification or contain enough calcium for core biopsies Small palpable carcinoma (T1 or T2) with no palpable axillary lymph nodes (N0) No definitive local therapy Atypical hyperplasia (ductal or lobular) and/or carcinoma on initial diagnostic biopsy Hormone receptor status: Not specified
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1 Tamoxifen + Fenretinide
Tamoxifen + Fenretinide daily for 14-28 days
|
Daily for 14-28 days.
Other Names:
Daily for 14-28 days.
Other Names:
|
Placebo Comparator: Arm 2 Placebo
Placebo daily for 14-28 days
|
Daily for 14-28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sonja E. Singletary, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protective Agents
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Anticarcinogenic Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Fenretinide
- Tamoxifen
- Retinamide
Other Study ID Numbers
- ID94-029
- P30CA016672 (U.S. NIH Grant/Contract)
- MDA-ID-94029 (Other Identifier: UT MD Anderson Cancer Center)
- NCI-P97-0113
- CDR0000065829 (Registry Identifier: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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