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Monoclonal Antibodies
Margetuximab vs Trastuzumab Combinations for Breast Cancer (MARGOT Trial)
Phase 2
Recruiting
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 belowSelect...
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.
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 moreMARGOT 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
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,763 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently dealing with an infection that needs treatment.I have received treatments for my current breast cancer.Women who could become pregnant must have a negative pregnancy test within 14 days before starting treatment.I do not have any serious diseases that could affect my treatment.Both of my breast cancers are HER2 positive, or one is small and ER+.My recent tests show my organs are functioning well.I am willing to have a breast biopsy for research.My breast cancer is at stage II or III and the tumor is at least 1.5 cm big.I can safely receive radiation therapy for my breast cancer.My genetic test shows I have a low affinity CD16 type.My cancer is HER-2 positive according to the latest guidelines.My cancer's hormone receptor status has been tested.I have not had invasive breast cancer in the last 5 years.I have high blood pressure or heart problems that are not well-managed.My doctor treats my multiple tumor sites as HER2 positive.I have not received IV antibiotics for an infection in the last 7 days.I experience noticeable discomfort or pain from nerve damage.I have had an ultrasound of the underarm area on the same side as my breast cancer.I am fully active or can carry out light work.I have had ductal or lobular carcinoma in situ in either breast.I am willing to use effective birth control methods if I or my partner can become pregnant.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Paclitaxel + Pertuzumab + Margetuximab
- Group 2: Paclitaxel + Pertuzumab + Trastuzumab
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.
Are there any other experiments that have been conducted to explore the efficacy of Margetuximab?
"At present, there are 978 ongoing clinical tests researching Margetuximab with 258 of them in the final phase. Most trials for this drug are conducted out of Seattle, yet over 54 thousand sites worldwide actively run experiments on its efficacy."
Answered by AI
Is Margetuximab a dependable medication for individuals?
"As it is currently a Phase 2 trial, with evidence of safety but lacking data on efficacy, Margetuximab received a score of 2."
Answered by AI
How has Margetuximab been utilized in the healthcare field?
"Margetuximab is frequently used to address metastatic bladder cancer, though it has been known to treat other maladies such as acquired immunodeficiency syndrome, inflammatory breast cancer (IBC), and advanced thymoma."
Answered by AI
Are there currently still opportunities to participate in this clinical venture?
"Clinicaltrials.gov confirms that this investigation is accepting participants, after being initially announced on July 13th 2020 and subsequently edited November 22nd 2022."
Answered by AI
How many participants is this trial enrolling?
"Affirmative. Clinicaltrials.gov reveals that this research has begun recruiting participants, first posted on July 13th 2020 and last updated November 22nd 2022. A total of 171 individuals have been sought for the trial, taking place at 16 facilities across the US."
Answered by AI
How many medical facilities have initiated this experiment?
"Currently, this medical trial is enrolling patients at 16 locations. These sites are situated in Foxboro, Milford and Pittsburgh; as well as 14 additional places. To reduce the hassle of travelling far distances to partake in the study, it's best if applicants choose a site nearby them."
Answered by AI
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