A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer
NCT ID: NCT00001378
Last Updated: 2008-03-04
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
PHASE1
75 participants
INTERVENTIONAL
1994-01-31
2000-11-30
Brief Summary
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Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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fenretinide
Eligibility Criteria
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Inclusion Criteria
No prior chemotherapy or hormonal therapy for invasive breast cancer.
At least 3 months since estrogen or progesterone replacement therapy or hormonal contraceptives.
PATIENT CHARACTERISTICS:
Age: 35 and over.
Performance status: Ambulatory.
Life expectancy: At least 10 years.
Hematopoietic: Complete blood count normal.
Hepatic:
Bilirubin normal.
Alkaline phosphate normal.
AST normal.
PT, PTT normal.
No history of bleeding disorder.
No history of chronic hepatitis or cirrhosis.
Renal:Creatinine less than 1.5 mg/dL.
Cardiovascular:
No history of deep venous thrombosis.
No history of pulmonary embolus.
Other:
No allergy to any study medication.
Capable of tolerating multiple diagnostic procedures.
No history of abnormal vaginal bleeding. Hysterectomy for vaginal bleeding of benign etiology allowed.
No history of retinal disease, macular degeneration, or night blindness.
No medical or psychiatric risk due to nonmalignant systemic disease that would preclude study participation.
No history of malignancy except: Curatively treated nonmelanomatous skin cancer. Curatively treated in situ cervical carcinoma. Hodgkin's disease treated more than 5 years ago.
No pregnant women.
Adequate contraception required of fertile patients during and for 12 months after fenretinide and for 2 months after tamoxifen.
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Locations
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National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
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References
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London SJ, Connolly JL, Schnitt SJ, Colditz GA. A prospective study of benign breast disease and the risk of breast cancer. JAMA. 1992 Feb 19;267(7):941-4.
Dupont WD, Page DL. Risk factors for breast cancer in women with proliferative breast disease. N Engl J Med. 1985 Jan 17;312(3):146-51. doi: 10.1056/NEJM198501173120303.
Other Identifiers
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94-C-0056
Identifier Type: -
Identifier Source: secondary_id
940056
Identifier Type: -
Identifier Source: org_study_id
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