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

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Estradiol; Fulvestrant; Trastuzumab

Criteria

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