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

NCT03767335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-06-26

Study results available
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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

Conditions

  • Advanced or Metastatic Breast Cancer

Interventions

DRUG

MEN1611

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

DRUG

Trastuzumab

Trastuzumab solution for infusion administered weekly via IV

DRUG

Fulvestrant

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

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Martine Piccart, MD PhD · Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2024-02-23
Completion
2024-02-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767335 on ClinicalTrials.gov