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ACTIVE NOT RECRUITING
NCT04425018
PHASE2

MARGetuximab Or Trastuzumab (MARGOT)

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

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)

Official title: MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

174

Start Date

2020-07-13

Completion Date

2027-07-01

Last Updated

2025-11-18

Healthy Volunteers

No

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.

Locations (14)

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Brigham Cancer Center - Foxborough

Foxborough, Massachusetts, United States

Dana-Farber at Milford

Milford, Massachusetts, United States

Dana-Farber at South Shore Hospital

Weymouth, Massachusetts, United States

Montefiore Medical Center

The Bronx, New York, United States

UPMC Hillman Cancer Center - Arnold Palmer at Mountain View

Greensburg, Pennsylvania, United States

UPMC Hillman Cancer Center - Arnold Palmer at Norwin

Irwin, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine Medical Center

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington Fred Hutchinson Cancer Care

Seattle, Washington, United States