MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
NCT ID: NCT03767335
Last Updated: 2025-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2018-11-13
2024-02-23
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MEN1611
MEN1611 + Trastuzumab +/- Fulvestrant
MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle
Trastuzumab
Trastuzumab solution for infusion administered weekly via IV
Fulvestrant
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)
Interventions
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MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle
Trastuzumab
Trastuzumab solution for infusion administered weekly via IV
Fulvestrant
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Menarini Group
INDUSTRY
Responsible Party
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Principal Investigators
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Martine Piccart, MD PhD
Role: STUDY_CHAIR
Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium
Locations
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Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Washington University
St Louis, Missouri, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Institut Régional du Cancer de Montpellier
Montferrier-sur-Lez, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Institut Claudius Regaud Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, , Italy
Istituto Clinico Humanitas
Milan, , Italy
Istituto Europeo di Oncologia (IEO)
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
START Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Velindre Cancer Centre
Cardiff, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Countries
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References
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Fiascarelli 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004631-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MEN1611-01
Identifier Type: -
Identifier Source: org_study_id
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