A Multicenter, Open-label, Single-arm Study of a Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2- Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Inclusion Criteria:
- Adult male or female patients, >/= 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast with
metastatic or locally recurrent disease not amenable to curative resection
- HER2-positive breast cancer
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Left ventricular ejection fraction (LVEF) of at least 50%
Exclusion Criteria:
- Previous systemic non-hormonal anti-cancer therapy for metastatic or locally
recurrent disease
- Disease-free interval from completion of adjuvant or neoadjuvant systemic
non-hormonal treatment to recurrence = 6 months
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment
setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant
setting
- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or
neoadjuvant setting
- History of persistent Grade 2 or higher (NCI-CTC, Version 4.0) hematological toxicity
resulting from previous adjuvant or neoadjuvant therapy
- Central nervous system (CNS) metastases
- Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
- History of other malignancy within the last 5 years prior to 1st study drug
administration, except for carcinoma in situ of the cervix or basal cell carcinoma
- Inadequate bone marrow, liver or renal function
- Uncontrolled hypertension
- Hepatitis B, hepatitis C or HIV infection