Abbreviations
PERT+TRAS+doce
PLB+TRAS+doce
402
406
Phase:
3
Double blind
Breast
HER2 poz.
meta
L1
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Participants with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; participants with de novo Stage IV disease are eligible) - Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) - Left ventricular ejection fraction (LVEF) ≥50 percent (%) at baseline (within 42 days of randomization) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment
- History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC, which must be stopped prior to randomization) - History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting - History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<)12 months - History of persistent Grade ≥2 hematologic toxicity resulting from previous adjuvant therapy - Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria for Adverse Events (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, basal cell carcinoma or squamous cell carcinoma