Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Laura Huppert, MD, BA.
NCT03095352 is a Phase 2 study that has completed, run by Laura Huppert, MD, BA. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of participants with Complete response (CR), Partial Response (PR), and stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 18 weeks of treatment in breast cancer patients with chest wall disease treated with pembrolizumab and carboplatin (Arm A) or carboplatin alone (Arm B) will be reported.
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 |
What the finished NCT03095352 record still lists
NCT03095352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03095352 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095352's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02615184 · 76 participants · Phase 2
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
- NCT02821741 · 76 participants · NA
Effects of External Ear Stimulation on Pain Perception and Mood
- NCT03019757 · 76 participants
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- NCT03353584 · 76 participants · NA
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI