Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

MEN1611-01

The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

2018-07-19

2023-12-21

2023-12-21

Active (not recruiting)

Early phase I

62

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Step 1 Dose escalation / Step 2 Cohort expansion in two selected breast cancer sub-populations', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ACTUAL'}}

2023-05-24