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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
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)
This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer. * The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits. * Participants will be randomized, which means randomly assigned, to one of two treatment arms. The treatment arms in this study and the names of the study drugs in each arm are: * Arm A: Paclitaxel, Pertzumab and Margetuximab * Arm B: Paclitaxel, Pertzumab and Trastuzumab Participants will receive study treatment for 12 weeks prior to surgery and will be followed for 10 years after surgery. After surgery, some participants will continue to receive the study drug margetuximab for a year in total, if they respond very well to the first 12 weeks of treatment with margetuximab. It is expected that about 171 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied. The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III HER2-positive breast cancer. The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced HER2-positive breast cancer.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 13, 2020
Primary Completion Date
October 24, 2024
Completion Date
July 1, 2027
Last Updated
November 18, 2025
174
ACTUAL participants
Paclitaxel
DRUG
Pertuzumab
DRUG
Margetuximab
DRUG
Trastuzumab
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
Collaborators
NCT05245812
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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