A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) and A Taxane in First-Line Treatment in Patients With HER2-Positive Advanced Breast Cancer (PERUSE)

• Progression-free survival, tumor assessments according to RECIST version1.1 criteria [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Overall response rate (partial response plus complete response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Clinical benefit rate (partial response or complete response or stable disease for >/= 6 months) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Duration of response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Time to response (patients with best response of partial response or complete response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
• Quality of life: Functional Assessment of Cancer Therapy-Breast [FACT-B] questionnaire (female patients only) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

This multicenter, open-label, single-arm study will evaluate the safety and tolerability of pertuzumab in combination with Herceptin (trastuzumab) and a taxane in first-line treatment in patients with metastatic or locally recurrent HER2-positive breast cancer. Patients will receive pertuzumab 840 mg intravenously (iv) and Herceptin 8 mg/kg iv plus a taxane on Day 1 of Cycle 1, followed by pertuzumab 420 mg iv and Herceptin 6 mg/kg iv plus a taxane on Day 1 of each subsequent 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

• Drug: pertuzumab
  840 mg iv on Day 1 of Cycle 1, followed by 420 mg iv on Day 1 of each subsequent 3-week cycle
• Drug: trastuzumab [Herceptin]
  8 mg/kg iv on Day 1 of Cycle 1, followed by 6 mg/kg iv on Day 1 of each subsequent 3-week cycle, administered in line with the product information
• Drug: taxane
  docetaxel or paclitaxel or nab-paclitaxel, administered in line with the respective product information

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