NCT03767335

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	MEN1611	MEN1611 oral dose administered twice daily for a continuous 28-day cycle
DRUG	Trastuzumab	Trastuzumab solution for infusion administered weekly via IV
DRUG	Fulvestrant	Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)

Timeline

• Start date: 2018-11-13
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2018-12-06
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

27 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study