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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 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 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03125928
The ClinicalTrials.gov registry entry for NCT03125928 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.