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NCT03449238 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
A Phase 1 study of Metastatic Breast Cancer and Brain Metastases, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 3
- Study locations
NCT03449238: Recruiting Phase 1 study of Metastatic Breast Cancer and Brain Metastases, sponsored by Weill Medical College of Cornell University.
NCT03449238 is a Phase 1 study of Metastatic Breast Cancer and Brain Metastases that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 41 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449238, a Phase 1 study of Metastatic Breast Cancer and Brain Metastases, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 3
- Study locations
Study Summary
Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.
Primary Outcome
detect abscopal responses in non-irradiated brain metastases, followed at routine post SRS brain MRI (evaluated at 8 weeks post-treatment, +/- one week) according to Response Evaluation criteria in Solid Tumors (RECIST1.1)
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (3)
New York
- Weill Cornell Medicine - New York
- Brooklyn Methodist Hospital - NewYork Presbyterian - New York
- New York Presbyterian Hospital - Queens - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
What NCT03449238 shows while recruiting
NCT03449238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03449238 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03449238 about?
NCT03449238 is a clinical study titled "Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients". Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg ...
What is the current status of trial NCT03449238?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-11-15. Estimated completion is 2030-12-31.
What conditions does trial NCT03449238 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Brain Metastases.
What interventions are being tested in trial NCT03449238?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03449238?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449238 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03449238's enrollment target sits among peer trials
41 90th of 139 higher than 48 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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.
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