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NCT03213041 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
A Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03213041: Recruiting Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Northwestern University.
NCT03213041 is a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 100 participants, above the 63-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (59% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03213041, a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.
Primary Outcome
PFS will be based on investigator assessment. PFS will be defined as the time from the first study treatment to the first occurrence of progression or death, and will be assessed every 9 weeks after beginning of treatment.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2023-07 |
| Phase | Phase 2 |
What NCT03213041 shows while recruiting
NCT03213041 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (59% higher).
The record links to 7 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03213041 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03213041 about?
NCT03213041 is a clinical study titled "Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer". The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies ...
What is the current status of trial NCT03213041?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-09-14. Estimated completion is 2023-07.
What conditions does trial NCT03213041 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, Estrogen Receptor Negative.
What interventions are being tested in trial NCT03213041?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT03213041?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03213041 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT03213041's enrollment target sits among peer trials
100 4th of 30 higher than 27 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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