SCCA Breast Cancer Clinical Trials

This two-cohort, open-label, multicenter, phase II study will assess the safety and efficacy of pertuzumab given in combination with Herceptin (trastuzumab) and vinorelbine in first line in patients with metastatic or locally advanced HER2-positive breast cancer. Patients will receive pertuzumab 840 mg and Herceptin 8 mg/kg administered sequentially as separate iv infusions on Day 1 of Cycle 1. From Cycle 2 onwards, patients will receive pertuzumab 420 mg and Herceptin 6 mg/kg, administered either sequentially as separate iv infusions (Cohort 1) or together in one infusion bag (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2 iv on Days 1 and 8 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 of each following 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, or withdrawal of consent or death.

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
• HER2-positive as assessed by local laboratory on primary or metastatic tumor
• At least one measurable lesion and/or non-measurable disease evaluable according to RECIST version 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Left ventricular ejection fraction (LVEF) of at least 55%
• Life expectancy of at least 12 weeks

• Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced setting
• Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
• History of persistent Grade 2 or higher (NCI-CTC Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
• Radiographic evidence of central nervous system (CNS) metastases
• Current peripheral neuropathy of Grade 3 or greater
• History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
• Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the patients at high risk for treatment -related complications
• Inadequate hematologic, liver or renal function
• Uncontrolled hypertension or clinically significant cardiovascular disease
• Hepatitis B, hepatitis C or HIV infection
• Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids