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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

Must not have

Active, unresolved infection requiring intervention

Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years from definitive surgery.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently dealing with an infection that needs treatment.

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I have received treatments for my current breast cancer.

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I have not had invasive breast cancer in the last 5 years.

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I have high blood pressure or heart problems that are not well-managed.

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I experience noticeable discomfort or pain from nerve damage.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of pathologic complete response (pCR)

Secondary study objectives

Event-free survival rate (EFS)

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

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

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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