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NCT03018080 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03018080 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 40 participants.
The verdict
NCT03018080, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4 treatment-related adverse event rate for each cohort and compare them to relevant historical controls.
Interventions
- DRUG Pembrolizumab
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2022-08-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03018080
The ClinicalTrials.gov registry entry for NCT03018080 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03018080 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03018080 about?
NCT03018080 is a clinical study titled "Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer". The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. The primary safety ...
What is the current status of trial NCT03018080?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-06-12. Estimated completion is 2022-08-05.
What interventions are being tested in trial NCT03018080?
The interventions under investigation include: Pembrolizumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03018080?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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