CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 62 enrolled
Drug / intervention
MEN1611 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03767335
NCT03767335Phase 1Completed
CompareCT.gov

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

Menarini Group·interventional·Posted Dec 6, 2018·Updated Jun 26, 2025

In Brief

A Phase 1 clinical trial evaluating MEN1611, Trastuzumab, and 1 other intervention for Advanced or Metastatic Breast Cancer. Completed, enrolled 62 participants across 27 sites in 6 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Metastatic Breast Cancer
CountriesBelgium, France, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 6, 2018
Enrollment StartNov 13, 2018
Primary CompletionFeb 23, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.6 years ago

Interventions

MEN1611drug

MEN1611 oral dose administered twice daily for a continuous 28-day cycle

Trastuzumabdrug

Trastuzumab solution for infusion administered weekly via IV

Fulvestrantdrug

Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)