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NCT04425018 · ClinicalTrials.gov registry record · Phase 2
MARGetuximab Or Trastuzumab (MARGOT)
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 14
- Study locations
NCT04425018: Active Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04425018 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 174 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04425018, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 14
- Study locations
Study 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)
Primary Outcome
Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the re
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Pertuzumab
- DRUG Margetuximab
Study Locations (14)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
- Dana-Farber Brigham Cancer Center - Foxborough - Foxborough
- Dana-Farber at Milford - Milford
- Dana-Farber at South Shore Hospital - Weymouth
Pennsylvania
- UPMC Hillman Cancer Center - Arnold Palmer at Mountain View - Greensburg
- UPMC Hillman Cancer Center - Arnold Palmer at Norwin - Irwin
- University of Pittsburgh Medical Center - Pittsburgh
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
Texas
- Baylor College of Medicine Medical Center - Houston
- MD Anderson Cancer Center - Houston
New York
- Montefiore Medical Center - The Bronx
Washington
- University of Washington Fred Hutchinson Cancer Care - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
What the registry record for NCT04425018 still lists
NCT04425018 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT04425018 lists 14 locations in 6 states (Massachusetts, Pennsylvania, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT04425018 about?
NCT04425018 is a clinical study titled "MARGetuximab Or Trastuzumab (MARGOT)". 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, Pertzuma...
What is the current status of trial NCT04425018?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2020-07-13. Estimated completion is 2027-07-01.
What conditions does trial NCT04425018 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer.
What interventions are being tested in trial NCT04425018?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG), Margetuximab (DRUG).
Who is sponsoring clinical trial NCT04425018?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04425018 being conducted?
This trial has 14 study locations across District of Columbia, Massachusetts, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04425018's enrollment target sits among peer trials
174 418th of 1224 higher than 807 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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