Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| MEN1611 | Drug | Izorlisib | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEN1611
- description
- MEN1611 + Trastuzumab +/- Fulvestrant
- interventionNames
- Drug: MEN1611
- Drug: Trastuzumab
- Drug: Fulvestrant
Primary outcomes (3)
- measure
- MTD of MEN1611 in Combination With Trastuzumab ± Fulvestrant
- timeFrame
- Up to 28 Days
- description
- MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window.
- measure
- Number of Participants With DLTs of MEN1611 in Combination With Trastuzumab ± Fulvestrant
- timeFrame
- Up to 28 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFiascarelli A, Merlino G, Capano S, Talucci S, Bisignano D, Bressan A, Bellarosa D, Carrisi C, Paoli A, Bigioni M, Tunici P, Irrissuto C, Salerno M, Arribas J, de Stanchina E, Scaltriti M, Binaschi M. Antitumor activity of the PI3K delta-sparing inhibitor MEN1611 in PIK3CA mutated, trastuzumab-resistant HER2 + breast cancer. Breast Cancer Res Treat. 2023 May;199(1):13-23. doi: 10.1007/s10549-023-06895-2. Epub 2023 Mar 13. PMID 36913051