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PI3K inhibitor

MEN1611 + Trastuzumab for Breast Cancer (B-PRECISE-01 Trial)

Phase 1
Waitlist Available
Research Sponsored by Menarini Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

B-PRECISE-01 Trial Summary

This trial tests a drug combination to treat advanced or metastatic HER2-positive breast cancer.

Who is the study for?
This trial is for adults with advanced HER2-positive breast cancer that has a specific mutation (PIK3CA) and has worsened after at least two anti-HER2 treatments. Participants must have a life expectancy of at least 12 weeks, be relatively active (ECOG ≤ 2), and cannot have untreated brain metastases, serious heart or bowel disease, uncontrolled diabetes, or be on chronic steroids.Check my eligibility
What is being tested?
The study is testing the safety and optimal dose of MEN1611 in combination with Trastuzumab, with or without Fulvestrant. It's an early-phase trial for those whose breast cancer has spread and who've had previous treatments targeting the HER2 protein.See study design
What are the potential side effects?
Potential side effects may include digestive issues like diarrhea (since patients with significant bowel disease are excluded), blood sugar problems (as those with uncontrolled diabetes can't participate), and possibly immune system effects due to restrictions on steroid use.

B-PRECISE-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
You have advanced or spreading breast cancer with a specific mutation called PIK3CA.
You have tried at least two different treatments for HER2-positive cancer, including one with trastuzumab.
You are expected to live for at least 12 more weeks.

B-PRECISE-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D)
Secondary outcome measures
Overall Survival
Progression Free Survival
Treatment emergent adverse events (TEAEs)

B-PRECISE-01 Trial Design

1Treatment groups
Experimental Treatment
Group I: MEN1611Experimental Treatment3 Interventions
MEN1611 + Trastuzumab +/- Fulvestrant
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Completed Phase 3

Find a Location

Who is running the clinical trial?

Menarini GroupLead Sponsor
42 Previous Clinical Trials
11,764 Total Patients Enrolled
1 Trials studying Breast Cancer
28 Patients Enrolled for Breast Cancer
Martine Piccart, MD PhDStudy ChairInstitute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium

Media Library

MEN1611 (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03767335 — Phase 1
Breast Cancer Research Study Groups: MEN1611
Breast Cancer Clinical Trial 2023: MEN1611 Highlights & Side Effects. Trial Name: NCT03767335 — Phase 1
MEN1611 (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767335 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Apr 2025