Clinical trial NCT00002864 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: octreotide acetate, tamoxifen citrate
SMILES: [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 proven adenocarcinoma of the breast that is
        potentially curable Prior treatment with one of the following therapies required: Segmental
        mastectomy (lumpectomy) followed by radiotherapy Chest wall irradiation allowed only in
        patients with T4 dermal involvement on pathologic diagnosis Further excision or boost
        radiotherapy to the tumor bed recommended if microscopic disease found at mastectomy
        margins Total mastectomy Chest wall irradiation required if microscopic disease found at
        mastectomy margins Clinical stage T1-3a N0-2 M0 disease prior to surgery The following T4
        features exclude: Chest wall extension Edema (including peau d'orange) Skin ulceration
        Satellite skin nodules confined to same breast Inflammatory carcinoma Pathologic stage T1-4
        NX-2 M0 disease following surgery Eligible T4 tumors are those with dermal involvement on
        pathology assessment only Pathologic assessment of axillary lymph nodes required May be
        omitted in patients with clinical N0 status provided other entry criteria are met No
        bilateral breast cancer without complete resection of both sides Hormone receptor status:
        Estrogen and progesterone receptor status determined from primary tumor when possible by
        quantitative biochemical methods or immunohistochemistry Results recorded as positive or
        negative if immunohistochemistry used Unknown status does not exclude provided other entry
        criteria are met

        PATIENT CHARACTERISTICS: Age: Postmenopausal Sex: Women only Menopausal status:
        Postmenopausal by one or more of the following: Amenorrhea lasting more than 1 year in
        women under 50 years of age with no prior hysterectomy No menses for 6 months prior to
        breast surgery in women 50 years of age and over with no prior hysterectomy Documented
        oophorectomy prior to breast cancer diagnosis Luteinizing hormone and follicle-stimulating
        hormone values diagnostic of postmenopausal status by local laboratory criteria Women 50
        years of age and over with prior hysterectomy Performance status: ECOG 0-2 Life expectancy:
        At least 5 years Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
        Hepatic: (unless metastatic disease ruled out by radiologic exam) AST or ALT less than
        twice normal Alkaline phosphatase less than twice normal Renal: Not specified Other: No
        symptomatic gallbladder disease or cholecystitis No intercurrent illness that reduces life
        expectancy to less than 5 years No other major medical or psychiatric illness that
        precludes study treatment or follow-up No second malignancy within 5 years except:
        Adequately treated basal cell skin carcinoma Adequately treated cancer of the cervix,
        endometrium, colon, or thyroid Able and willing to complete quality-of-life questionnaires
        in English or French Illiteracy, loss of sight, or other inability to complete
        questionnaires does not exclude Accessible for treatment and follow-up

        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: Prior
        or concurrent adjuvant chemotherapy allowed at investigator's discretion Recommended
        regimens: CMF (cyclophosphamide/methotrexate/fluorouracil) CEF
        (cyclophosphamide/etoposide/fluorouracil) AC (doxorubicin/cyclophosphamide) Choice of
        adjuvant chemotherapy regimen defined prior to randomization if given concurrently with
        protocol therapy Endocrine therapy: No estrogen, progestins, or androgen therapy for a
        period of more than 30 days following pathologic diagnosis of breast cancer Prior tamoxifen
        allowed All hormonal therapy discontinued prior to randomization Radiotherapy: See Disease
        Characteristics Surgery: See Disease Characteristics