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Monoclonal Antibodies

Margetuximab vs Trastuzumab Combinations for Breast Cancer (MARGOT Trial)

Phase 2

Waitlist Available

Led By Ian E Krop, MD, PHD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Required laboratory values demonstrating adequate organ function

Willing to undergo breast biopsy for research purposes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years from definitive surgery.

Awards & highlights

MARGOT Trial Summary

This trial is testing two different combinations of drugs to see how well they work in treating HER2-positive stage II-III breast cancer.

Who is the study for?

This trial is for adults over 18 with stage II-III HER2-positive breast cancer, who haven't had invasive breast cancer in the past 5 years or any treatment for their current cancer. Participants must have proper organ function and a specific genetic profile (CD16 FF/FV). Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The MARGOT study tests how well patients respond to pre-surgery drug combinations: Paclitaxel with Pertuzumab plus either Margetuximab or Trastuzumab. The goal is to compare these two regimens' effectiveness in treating early-stage HER2-positive breast cancer.See study design

What are the potential side effects?

Potential side effects include allergic reactions, fatigue, nausea, hair loss from Paclitaxel; heart issues from Trastuzumab; infusion-related reactions from both Margetuximab and Pertuzumab. Side effects can vary based on individual health conditions.

MARGOT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent tests show my organs are functioning well.

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I am willing to have a breast biopsy for research.

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My breast cancer is at stage II or III and the tumor is at least 1.5 cm big.

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I can safely receive radiation therapy for my breast cancer.

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My genetic test shows I have a low affinity CD16 type.

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My cancer is HER-2 positive according to the latest guidelines.

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My cancer's hormone receptor status has been tested.

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I am fully active or can carry out light work.

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I have had ductal or lobular carcinoma in situ in either breast.

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I am willing to use effective birth control methods if I or my partner can become pregnant.

MARGOT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years from definitive surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years from definitive surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years from definitive surgery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of pathologic complete response (pCR)

Secondary outcome measures

Event-free survival rate (EFS)

Event-free survival rate (EFS) -Patients with pCR

Event-free survival rate (EFS) -Patients without pCR

+22 more

MARGOT Trial Design

2Treatment groups

Experimental Treatment

Group I: Paclitaxel + Pertuzumab + TrastuzumabExperimental Treatment3 Interventions

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days Paclitaxel- via IV, Day 1,8,15 of each cycle Pertuzumab via IV, Day 1 of each cycle Trastuzumab via IV, Day 1 of each cycle

Group II: Paclitaxel + Pertuzumab + MargetuximabExperimental Treatment3 Interventions

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days Paclitaxel- via IV, Day 1,8,15 of each cycle Margetuximab via IV, Day 1 of each cycle Pertuzumab via IV, Day 1 of each cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Margetuximab

2013

Completed Phase 3

~650

Trastuzumab

2014

Completed Phase 4

~5190

Paclitaxel

2011

Completed Phase 4

~5380

Pertuzumab

2014

Completed Phase 3

~7500

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

340,756 Total Patients Enrolled

141 Trials studying Breast Cancer

22,446 Patients Enrolled for Breast Cancer

MacroGenicsIndustry Sponsor

48 Previous Clinical Trials

5,205 Total Patients Enrolled

3 Trials studying Breast Cancer

158 Patients Enrolled for Breast Cancer

Translational Breast Cancer Research ConsortiumOTHER

22 Previous Clinical Trials

2,172 Total Patients Enrolled

12 Trials studying Breast Cancer

1,390 Patients Enrolled for Breast Cancer

Media Library

Margetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04425018 — Phase 2

Breast Cancer Research Study Groups: Paclitaxel + Pertuzumab + Margetuximab, Paclitaxel + Pertuzumab + Trastuzumab

Breast Cancer Clinical Trial 2023: Margetuximab Highlights & Side Effects. Trial Name: NCT04425018 — Phase 2

Margetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04425018 — Phase 2

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