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

Trial Status: Active

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

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

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


University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Nancy S. Tait
Phone: 410-328-3546


Saint Louis
Siteman Cancer Center at Washington University

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


Trial Phase Phase I

Trial Type Treatment

Lead Organization
Menarini Group

  • Primary ID MEN1611-01
  • Secondary IDs NCI-2020-05553, 2017-004631-36
  • ID NCT03767335