Breast Cancer Clinical Trial
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
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
Full Description
This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease.
MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide 3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611 given in combination with Trastuzumab with/without Fulvestrant.
The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review Committee.
Eligibility 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
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There are 3 Locations for this study
Fort Lauderdale Florida, 33308, United States
Farmington Hills Michigan, 48334, United States
Saint Louis Missouri, 63130, United States
Brussels , , Belgium
Brussels , , Belgium
Leuven , , Belgium
Dijon , , France
Lille Cedex , , France
Montferrier Sur Lez , , France
Saint-Herblain , , France
Toulouse , , France
Villejuif cedex , , France
Catanzaro , , Italy
Milan , , Italy
Milan , , Italy
Milan , , Italy
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Málaga , , Spain
Sevilla , , Spain
Cardiff , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
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