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NCT03125928 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer
A Phase 2 study of HER2-positive Breast Cancer, sponsored by Fox Chase Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03125928: Active Phase 2 study of HER2-positive Breast Cancer, sponsored by Fox Chase Cancer Center.
NCT03125928 is a Phase 2 study of HER2-positive Breast Cancer that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 16 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03125928, a Phase 2 study of HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently. Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.
Primary Outcome
Treatment-related adverse events will be assessed by CTCAE v4.0
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Atezolizumab
- DRUG Paclitaxel
- DRUG Pertuzumab
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT03125928 still lists
NCT03125928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT03125928 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03125928 about?
NCT03125928 is a clinical study titled "Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer". This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may h...
What is the current status of trial NCT03125928?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2017-06-13. Estimated completion is 2025-12.
What conditions does trial NCT03125928 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer.
What interventions are being tested in trial NCT03125928?
The interventions under investigation include: Trastuzumab (DRUG), Atezolizumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT03125928?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03125928 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
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 NCT03125928's enrollment target sits among peer trials
16 54th of 58 higher than 5 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive 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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