For Healthcare Professionals

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


About the study

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

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Main Inclusion Criteria:

  1. Histologically confirmed invasive adenocarcinoma of the breast
  2. Known HER2+ breast cancer
  3. Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample
  4. > 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab
  5. Radiological documented evidence of progressive disease
  6. Life expectancy ≥ 12 weeks
  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2


Main Exclusion Criteria:

  1. Previous treatment with PI3K inhibitors
  2. Brain metastases untreated, unless treated > 4 weeks and only if clinically stable and not receiving corticosteroids
  3. History of clinically significant bowel disease
  4. ≥ grade 2 diarrhoea
  5. History of significant, uncontrolled, or active cardiovascular disease
  6. Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety
  7. Not controlled diabetes mellitus (glycated haemoglobin [HbA1c] >7%) and fasting plasma glucose >126 mg/dL
  8. Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Advanced or Metastatic Breast Cancer

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Dec 21, 2023

Treatment type



Menarini Group identifier


Study number


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