A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

Exclusion Criteria

• •Previous systemic treatment in palliative intention (chemotherapy, hormonal therapy and / or biological therapy)
• •Persistent peripheral sensory or motor neuropathy grade 2 or higher (NCI CTCAE v5.0)
• •Evidence of central nervous system metastases. CT or MRI of the brain is only mandatory in case of clinical suspicion of brain metastases
• •Current uncontrolled hypertension (systolic \> 150 mmHg and / or diastolic \> 100 mmHg) or clinically significant cardiovascular disease
• •History of LVEF \< 50% during or after prior (neo)adjuvant therapy with trastuzumab
• •Current severe, uncontrolled systemic disease (e.g. cardiovascular, pulmonary, or metabolic disease, wound healing disorder, ulcers, or bone fractures, or severe fungal, bacterial or viral infection)
• •Major surgery within 28 days prior to start of study medication, or anticipation of the need for major surgery during the course of study treatment
• •Current known infection with HIV, HBV, or HCV (testing not required)
• •Dyspnea at rest due to complications of advanced malignancy, or other diseases requiring continuous oxygen therapy.
• •Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
• •Participation in investigational studies within 30 days or five half-lives of the respective IMP, whichever is longer, prior randomization.
• •Pregnant or lactating women.