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Monoclonal Antibodies

Margetuximab vs Trastuzumab Combinations for Breast Cancer (MARGOT Trial)

Seattle, WA
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.

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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.

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.
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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.
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Timeline

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
~5210
Paclitaxel
2011
Completed Phase 4
~5450
Pertuzumab
2014
Completed Phase 3
~11320

Find a Location

Closest Location:MD Anderson Cancer Center· Houston, TX· 574 miles
Image of MD Anderson Cancer Center in Houston, United States.Image of MD Anderson Cancer Center in Houston, United States.Image of MD Anderson Cancer Center in Houston, United States.

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,126 Previous Clinical Trials
361,088 Total Patients Enrolled
145 Trials studying Breast Cancer
20,114 Patients Enrolled for Breast Cancer
MacroGenicsIndustry Sponsor
50 Previous Clinical Trials
5,186 Total Patients Enrolled
3 Trials studying Breast Cancer
158 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
26 Previous Clinical Trials
2,907 Total Patients Enrolled
14 Trials studying Breast Cancer
1,819 Patients Enrolled for Breast Cancer
Ian E Krop, MD, PHDPrincipal InvestigatorDana-Farber Cancer Institute
Adrienne Waks, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
40 Total Patients Enrolled

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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