Clinical trial NCT01964391 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: trastuzumab, doxorubicin, cyclophosphamide, paclitaxel, docetaxel, carboplatin, neo-adjuvant chemotherapy
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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, ClCCN(CCCl)P1(=O)NCCCO1, [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CCCNC(N)=N)C(O)=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
Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Hormonal therapy will be allowed as per institutional guidelines

          -  Prior use of anti-HER2 therapy will be allowed, except for early breast cancer
             participants in the neo-adjuvant setting

          -  Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent
             (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan
             prior to first dose of trastuzumab, or, for those who were receiving trastuzumab when
             beginning the study, documented results within an acceptable limit from a cardiac
             assessment within 3 months prior to enrollment

          -  HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization
             (ISH) positive as determined in a local laboratory that is experienced/certified in
             HER2-expression testing using an accurate and validated assay

          -  Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast

          -  No evidence of residual, locally recurrent or metastatic disease after completion of
             surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)

          -  Use of concurrent curative radiotherapy will be permitted

        Exclusion Criteria:

          -  History of other malignancy which could affect compliance with the protocol or
             interpretation of results. Participants with curatively treated carcinoma in situ of
             the cervix or basal cell carcinoma, and participants with other curatively treated
             malignancies who have been disease-free for at least 5 years, are eligible

          -  Severe dyspnea at rest or requirement for supplementary oxygen therapy

          -  Other concurrent serious diseases that may interfere with planned treatment, including
             severe pulmonary conditions/illness

          -  Serious cardiac illness or medical conditions that would preclude the use of
             trastuzumab, specifically: history of documented congestive heart failure (CHF),
             high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically
             significant valvular disease, evidence of transmural infarction on electrocardiogram
             (ECG), diagnosed poorly controlled hypertension

          -  Known infection with human immunodeficiency virus (HIV), active hepatitis B virus
             (HBV) or hepatitis C virus (HCV)

          -  Pregnant or lactating women

          -  Concurrent enrollment in another clinical trial using an investigational anti-cancer
             treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy,
             within 28 days prior to the first dose of study treatment

          -  Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of
             Herceptin, or a history of severe allergic or immunological reactions, e.g. difficult
             to control asthma

          -  Inadequate bone marrow, hepatic or renal function