Clinical trial NCT00002967 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, doxorubicin hydrochloride, octreotide pamoate, tamoxifen citrate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed Stage I, IIA or IIB invasive
        adenocarcinoma of the breast with T1-3, pN0 and M0 classification Must have undergone total
        mastectomy or lumpectomy followed by an axillary dissection or sentinel node resection if
        participating in NSABP B-32 Histologically negative axillary lymph nodes OR Histologically
        negative sentinel lymph nodes if participating in NSABP B-32 Lumpectomy and axillary
        dissection acceptable only if margins of resected specimen are histologically free of
        invasive tumor or ductal carcinoma in situ and other dominant masses within the ipsilateral
        breast remnant are histologically confirmed to be benign Additional operation after
        resection is allowed in order to obtain clear margins No bilateral malignancy of the breast
        ER positive tumors as defined by at least one of the following: At least 10 fmol/mg cytosol
        protein by either dextran-coated charcoal or sucrose density gradient methods Positive or
        not definitely negative results by the enzyme immunoassay method (EIA) or by
        immunocytochemical assay No more than 63 days from time of initial cytologic or histologic
        diagnosis of breast cancer till randomization No bone metastases (confirmation must be made
        for those with skeletal pain) Tumor must be no greater than 5 cm in its greatest dimension
        for patients who are treated by lumpectomy and axillary dissection Hormone receptor status:
        Estrogen receptor positive

        PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified
        Life expectancy: At least 10 years (excluding diagnosis of cancer) Performance status: Not
        specified Hematopoietic: WBC at least 4,000/mm3 Platelet count postoperative at least
        100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: Creatinine normal
        Cardiovascular: No cardiac disease that would preclude the use of doxorubicin (for patients
        who are to receive adjuvant chemotherapy in this study), including: Myocardial infarction
        Angina pectoris that requires antianginal medication History of congestive heart failure
        Arrhythmia associated with concurrent heart failure or cardiac dysfunction Valvular disease
        with cardiac compromise Cardiomegaly or ventricular hypertrophy unless left ventricular
        function is within normal limits Poorly controlled hypertension Other: No prior invasive
        breast cancer or ductal carcimoma in situ No systemic disease that would preclude patients
        from any part of study No history of symptomatic gallbladder or biliary tract disease
        unless patient has undergone cholecystectomy No ulceration, erythema, infiltration of the
        skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any
        magnitude No prior nonbreast malignancies in past 10 years except: Squamous or basal cell
        carcinoma of the skin that has been effectively treated Carcinoma in situ of the cervix
        that has been treated by operation only Lobular carcinoma in situ of the ipsilateral or
        contralateral breast treated by segmented resection only No psychiatric or addictive
        disorders Not pregnant or nursing Negative pregnancy test

        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer
        Chemotherapy: No prior chemotherapy for breast cancer No prior anthracycline therapy for
        patients who are to receive adjuvant chemotherapy in this study Endocrine therapy: No prior
        endocrine therapy for breast cancer Must discontinue any sex hormonal therapy before prior
        to and during study Radiotherapy: No prior radiotherapy for breast cancer No breast
        radiation therapy before randomization for patients who receive lumpectomy Surgery: See
        Disease Characteristics At least 2 weeks since last surgical procedure Other: No concurrent
        cyclosporine therapy No concurrent heparin or warfarin anticoagulation therapy