Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies

Exclusion Criteria

• •History of persistent Grade ≥ 2 hematologic toxicity resulting from previous systemic therapy
• •Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
• •History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
• •Bone-only disease, unless a measurable lesion is evident as determined by RECIST v1.1
• •Bone scan, PET scan or plain films are not considered adequate imaging techniques to measure bone lesions. ve
• •Blastic bone lesions are non-measurable.
• •Uncontrolled hypertension (systolic \>150 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease.
• •Current dyspnoea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy.
• •Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization.
• •Current severe, uncontrolled systemic disease
• •Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
• •History of receiving any investigational treatment within 28 days of randomization
• •Current known infection with HIV, HBV, or HCV
• •Receipt of IV antibiotics for infection within 14 days of randomization
• •Known hypersensitivity to any of the study drugs
• •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• •Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
• •Concurrent interventional or non-interventional studies