PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin

Exclusion criteria

• ✕. Current participation in another therapeutic clinical trial.
• ✕. Extra-cranial radiotherapy or limited-field palliative radiotherapy within 7 days prior to Study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade ≤ 1 and/or from whom ≥ 25% of the bone marrow has been previously irradiated.
• ✕. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 21 days of start of Study drug, or patients who have not recovered from the side effects of any major surgery.
• ✕. Patient with a concurrent malignancy or malignancy within 5 years of Study enrollment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer.
• ✕. Treatment with approved chemotherapy/immunotherapy/ targeted agents within 21 days prior to initiation of Study, or treatment with an investigational cancer therapy for 21 days or 5 half-lives (whichever is longer) prior to initiation of any Study treatment.
• ✕. Patient with cerebrovascular accident or transient ischemic attack within 6 months prior to the start of any Study treatment.
• ✕. Congenital long QT syndrome or screening QT interval corrected using Fridericia's formula (QTcF) \> 480 milliseconds.
• ✕. Patient with an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including any of the following: