Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

Exclusion Criteria

• •Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.
• •Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.
• •Preexisting peripheral neuropathy ≥ grade 2
• •Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
• •Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;
• •Unresolved or unstable, serious adverse events from prior administration of another investigational drug;
• •Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
• •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
• •Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);
• •Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
• •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;
• •Pregnant or lactating women;
• •Concomitant use of CYP3A4 inhibitors or inducers
• •Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
• •Patients have an active infection and require IV or oral antibiotics.
• •Pregnant or breast-feeding women
• •Patients unwilling or unable to comply with the protocol