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NCT04683679 · ClinicalTrials.gov registry record · Phase 2
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
A Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 7
- Study locations
NCT04683679: Recruiting Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04683679 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 34 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683679, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).
Primary Outcome
To assess overall response rate (ORR) to pembrolizumab + , SBRT + /-olaparib, in non-targeted unirradiated lesions at 8 weeks using RECIST v1.1 in patients with mTNBC who have progressed on ICI or are PD-L1 negative and mER+BC.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Olaparib
- RADIATION Radiation
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT04683679 shows while recruiting
NCT04683679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04683679 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04683679 about?
NCT04683679 is a clinical study titled "A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer". The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radia...
What is the current status of trial NCT04683679?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2021-04-21. Estimated completion is 2027-01.
What conditions does trial NCT04683679 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT04683679?
The interventions under investigation include: Pembrolizumab (DRUG), Olaparib (DRUG), Radiation (RADIATION).
Who is sponsoring clinical trial NCT04683679?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04683679 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04683679's enrollment target sits among peer trials
34 928th of 1224 higher than 291 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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