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NCT03095352 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease
A Phase 2 study, sponsored by Laura Huppert, MD, BA.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT03095352 is a Phase 2 study that has completed, run by Laura Huppert, MD, BA. The registered enrollment target is 76 participants.
The verdict
NCT03095352, a Phase 2 study, has completed, sponsored by Laura Huppert, MD, BA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (estrogen receptor (ER) positive/progesterone receptor (PR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer with progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR negative/HER2 negative, TNBC). A companion translational study is operating concurrently with the study described above. In this study, biomarker research to be performed on tumor biopsies and peripheral blood samples will be performed to explore the immunologic and genomic mechanism of action underlying treatment with pembrolizumab and carboplatin versus carboplatin alone. This protocol includes tissue and blood correlative exploratory endpoints including changes in tumor PD-L1 (programmed death ligand 1) gene expression, tumor and peripheral blood immune composition and cytokine expression, plasma tumor DNA, circulating tumor cells, and tumor myelocytomatosis (MYC) oncogene expression using tumor biopsy and peripheral blood testing before and after treatment; correlations with these markers and disease control rate will be assessed.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- BIOLOGICAL Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-09-02 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095352
The ClinicalTrials.gov registry entry for NCT03095352 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laura Huppert, MD, BA, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03095352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03095352 about?
NCT03095352 is a clinical study titled "Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease". This is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (estrogen receptor (ER) positive/progesterone receptor (PR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer with progressive disease on 2 prior line...
What is the current status of trial NCT03095352?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2017-09-02. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT03095352?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03095352?
This trial is sponsored by Laura Huppert, MD, BA, which has 3 total clinical trials registered on ClinicalTrials.gov.
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