Clinical trial NCT00038402 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: herceptin, taxol, fluorouracil, cytoxan, epirubicin
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, ClCCN(CCCl)P1(=O)NCCCO1, CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1
Eligibility criteria:

        Inclusion Criteria:

          1. All patients with histologic confirmation of invasive, but non-inflammatory carcinoma
             of the breast with T2-3 (greater than 2 cm), N0-1, M0 will be eligible. Patients with
             T1N1 (after histological confirmation of nodal disease) will be eligible for the
             study.

          2. Histologic confirmation of invasive tumor will be done by core needle biopsy. On the
             tissue obtained, estrogen and progesterone receptors (ER/PR) as well as Her-2/neu
             (will be determined by immunohistochemistry (IH) and/or fluorescence in situ
             hybridization (FISH)) and p53 will be done (for research evaluation). Tumor
             proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded
             sections and monoclonal antibody for ki-67. Residual tumor tissue will be saved in the
             tissue bank for further future studies.

          3. All patients who are Her-2/neu positive will be eligible for the study. Her-2/neu
             positivity for protocol purposes will be determined by IHC and patients with tumors
             that are 3+ or FISH + will be eligible.

          4. Patients must sign an informed consent indicating that they are aware of the
             investigational nature of the study, in keeping with institutional policy.

          5. All patients should have adequate bone marrow function, as defined by peripheral
             granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. Patients must have
             adequate liver function, with a bilirubin within normal laboratory values. In
             addition, patients should have adequate renal function, defined as serum creatinine
             <2.0 mg%.

          6. Patients must have a normal cardiac ejection fraction as determined by baseline
             echocardiogram. Tape must be saved for review by central cardiologist.

          7. Patients who underwent biopsy outside will be eligible if they had a measurable
             residual tumor.

          8. Patients with multicentric disease and extensive Ductal Carcinoma in Situ (DCIS) will
             be eligible for study.

          9. Patients with a history of cardiac arrhythmia will be eligible for study after being
             cleared by cardiology.

        Exclusion Criteria:

          1. Patients with T1N0 disease are not eligible for the study.

          2. Those patients with history of other invasive malignancies will be excluded except
             non-melanoma skin cancer and non-invasive cervical cancer.

          3. Patients with a history of congestive heart failure will be excluded.

          4. Patients who had surgical therapy prior to referral will be ineligible.