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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
Be older than 18 years old
Timeline
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Fulvestrant
2011
Completed Phase 3
~3690
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking long-term steroids or other medications that weaken the immune system.You have been diagnosed with invasive adenocarcinoma of the breast through a tissue sample.You have been diagnosed with HER2-positive breast cancer.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 have untreated brain metastases, unless they have been treated for more than 4 weeks and you are clinically stable and not taking corticosteroids.You have a history of a serious bowel disease.You have diarrhea that is moderate or worse.You have a history of serious heart problems that are not well managed or are currently happening.Your diabetes is not well controlled, with high levels of HbA1c and fasting plasma glucose.You have been treated with PI3K inhibitors before.Your medical scans show that the disease is getting worse.You are expected to live for at least 12 more weeks.You are able to perform daily activities with some limitations.
Research Study Groups:
This trial has the following groups:- Group 1: MEN1611
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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