Clinical trial NCT00002772 (phase 3, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: carboplatin, carmustine, cisplatin, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, tamoxifen citrate, thiotepa
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, ClCCNC(=O)N(CCCl)N=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, 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(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC, CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least 4
        involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal
        lymphatic involvement without clinical inflammatory changes (edema, peau d'orange,
        erythema) allowed Must have undergone breast conserving surgery or modified radical
        mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or
        noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since
        definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4
        weeks of initial histologic diagnosis One breast meets the eligibility criteria Other
        breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by
        modified radical mastectomy or breast conserving surgery with axillary node dissection
        Concurrent registration on S9719 Hormone receptor status: Not specified

        PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance
        status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at
        least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
        times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status
        required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular
        ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a
        cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No
        second or third degree heart block or other serious cardiac conduction abnormality No
        atrial or ventricular arrhythmia No requirement for medication known to affect cardiac
        conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a
        cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted
        Other: HIV negative Hepatitis B surface antigen status required No serious medical or
        psychiatric illness that would preclude informed consent or study participation No second
        malignancy within the past 5 years except adequately treated basal cell or squamous cell
        skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the
        breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective
        contraception

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
        chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy:
        No prior radiotherapy to the breast Surgery: See Disease Characteristics