Clinical trial NCT00482391 (phase 2, 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, lapatinib ditosylate, paclitaxel
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, CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1, [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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast

               -  Bilateral synchronous breast tumors allowed

               -  Any nodal status or tumor size allowed

                    -  No stage IV disease

          -  HER2/neu-positive disease

               -  3+ by IHC OR FISH-amplified

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Male or female

          -  Menopausal status not specified

          -  ECOG performance status 0-1

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.1 mg/dL

          -  SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and after completion
             of study therapy

          -  LVEF ≥ 50% by MUGA scan

          -  No peripheral neuropathy > grade 1

          -  No active second malignancy within the past 5 years except for adequately treated
             nonmelanoma skin cancer or in situ carcinoma of the cervix

          -  No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide,
             paclitaxel, or other drugs formulated in Cremophor EL

          -  No psychiatric illness or concurrent medical conditions that would preclude study
             treatment

          -  No other conditions, including any of the following:

               -  Unstable angina

               -  Congestive heart failure

               -  Myocardial infarction within the past 12 months

               -  High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV
                  block, or supraventricular arrhythmias that are not adequately controlled)

          -  No QT prolongation (> 500 ms)

          -  No active unresolved infections

          -  No sensitivity to E. coli derived proteins

        PRIOR CONCURRENT THERAPY:

          -  Prior hormonal therapy for chemoprevention allowed

          -  No prior trastuzumab (Herceptin®)

          -  No prior anthracyclines

          -  No concurrent hormonal therapy, including hormonal contraception (e.g., birth control
             pills or ovarian hormonal or replacement therapy)

          -  No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for
             breast cancer

          -  No concurrent drugs that may prolong the QT