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MARGetuximab Or Trastuzumab (MARGOT)

NCT04425018 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-11-18

Study results available
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Summary

The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs.

Drugs and Combinations used:

* Paclitaxel, Pertzumab and Margetuximab (Margenza)
* Paclitaxel, Pertzumab and Trastuzumab (Herceptin)

Conditions

Interventions

DRUG

Paclitaxel

Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.

DRUG

Pertuzumab

Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.

DRUG

Margetuximab

Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.

DRUG

Trastuzumab

Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Adrienne Waks, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2024-10-24
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425018 on ClinicalTrials.gov