MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

Criteria the registry did not label

• Main Inclusion Criteria:
• Histologically confirmed invasive adenocarcinoma of the breast
• Known HER2+ breast cancer
• Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample
• \> 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab
• Radiological documented evidence of progressive disease
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Main Exclusion Criteria:
• Previous treatment with PI3K inhibitors
• Brain metastases untreated, unless treated \> 4 weeks and only if clinically stable and not receiving corticosteroids
• History of clinically significant bowel disease
• ≥ grade 2 diarrhoea
• History of significant, uncontrolled, or active cardiovascular disease
• Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety
• Not controlled diabetes mellitus (glycated haemoglobin \[HbA1c\] \>7%) and fasting plasma glucose \>126 mg/dL
• Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent