Status:
COMPLETED
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
Lead Sponsor:
Menarini Group
Conditions:
Advanced or Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 treatmen...
Detailed 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 adv...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03767335
Start Date
November 13 2018
End Date
February 23 2024
Last Update
June 26 2025
Active Locations (27)
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1
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States, 33308
2
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
3
Washington University
St Louis, Missouri, United States, 63130
4
Cliniques Universitaires Saint-Luc
Brussels, Belgium