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NCT03747120 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 5
- Study locations
NCT03747120: Active Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT03747120 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 138 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03747120, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 5
- Study locations
Study Summary
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.
Primary Outcome
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery. \- Residual invasive cancer defined based on hematoxylin and eosin evaluation of complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathologist assessment.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Pertuzumab
Study Locations (5)
California
- Cedars Sinai Medical Center - Los Angeles
Massachusetts
- Massachusetts General Hospital - Boston
New Mexico
- New Mexico Cancer Center - Albuquerque
Oregon
- Providence Cancer Institute - Portland
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What the registry record for NCT03747120 still lists
NCT03747120 is an interventional study that assigns participants to a tested intervention. The registered 138 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 (95% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03747120 lists 5 locations in 5 states (California, Massachusetts, New Mexico).
Frequently Asked Questions
What is clinical trial NCT03747120 about?
NCT03747120 is a clinical study titled "Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]". A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrol...
What is the current status of trial NCT03747120?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2019-01-25. Estimated completion is 2029-12.
What conditions does trial NCT03747120 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer.
What interventions are being tested in trial NCT03747120?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT03747120?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03747120 being conducted?
This trial has 5 study locations across California, Massachusetts, New Mexico, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03747120's enrollment target sits among peer trials
138 471st of 1224 higher than 754 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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