Clinical trial NCT00002646 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fenretinide, tamoxifen citrate
SMILES: C\C(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Pathologic
        stage T1-3, N1-2, M0 No clinical or pathologic T4 disease No primary tumor fixed to chest
        wall No axillary nodes fixed to chest wall or neurovascular bundle No preoperative arm
        edema No clinical skin involvement (microscopic focal dermal invasion or dermal lymphatic
        involvement eligible) No clinical N2 disease Modified radical mastectomy or lumpectomy
        required prior to entry Sentinel node biopsy allowed Randomization required within 12 weeks
        from definitive surgery Surgery dated from mastectomy or axillary dissection for lumpectomy
        No positive deep mastectomy margins Radiotherapy planned within 12 weeks following axillary
        node dissection for lumpectomy patients Synchronous bilateral breast cancer eligible If
        tumor is at least 2 cm, then nodes not involved If no tumor is at least 2 cm, then at least
        1 node must be involved Both invasive primaries receptor-positive Previously treated,
        noninvasive breast cancer eligible No prior invasive breast cancer No adenoid cystic,
        squamous, or sarcomatous histology Hormone receptor status: Estrogen- or
        progesterone-receptor positive, i.e.: At least 10 fmole/mg cytosol protein by
        ligand-binding assay OR Receptor positive by immunocytochemistry

        PATIENT CHARACTERISTICS: Age: 65 and over OR Postmenopausal and ineligible/inappropriate
        for or declined other active node positive adjuvant studies Sex: Female Menopausal status:
        Postmenopausal, defined as: At least 1 year since last menstrual period Hysterectomized
        with bilateral oophorectomy Hysterectomized with 1 or both ovaries remaining and either:
        Over 60 FSH in postmenopausal range Not surgically castrated, under 60, and on HRT FSH
        elevated 2 weeks after HRT discontinued Performance status: Not specified Life expectancy:
        At least 7 years except for breast cancer Hematopoietic: WBC greater than 3,000/mm3
        Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no
        greater than 1.5 mg/dL AST less than 2 times normal Renal: Creatinine no greater than 2.0
        mg/dL BUN no greater than 25.0 mg/dL Other: No extensive macular degeneration on exam
        within 1 year of entry, e.g.: No exudative or atrophic macular lesions that reduce
        corrected vision to less than 20/40 Health adequate for protocol treatment No nutritional
        supplementation except single daily multivitamin No other vitamin A supplements Gynecologic
        exam within the past year required of women who retain a uterus No second malignancy within
        the past 10 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the
        cervix Prior noninvasive contralateral breast cancer

        PRIOR CONCURRENT THERAPY: No prior chemotherapy or hormonal therapy for breast cancer
        except: Up to 1 month of tamoxifen if started by a non participating physician At least 2
        weeks since hormone replacement therapy No concurrent megestrol