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NCT02538471 · ClinicalTrials.gov registry record · Phase 2
LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02538471: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT02538471 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02538471, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Patients with metastatic breast cancer receiving at least one single agent chemotherapy and demonstrating stable disease or disease progression at two consecutive clinical/radiological assessments (at an interval of at least 2 weeks). Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given consecutively on days 1-3-5.
Primary Outcome
Patients who have received at least one 14 days cycle of the study drug will be followed for toxicity (lack of grade 4 toxicity- primary safety end point). Physical exam (including labs) will be performed every 2 weeks while on the study. Patients will be followed with follow-up visits monthly for the first three months after completing therapy then annually for 5 years. Adverse Events will be monitored throughout the course of the study using the NCI CTCAE vers. 4.0.
Interventions
- RADIATION Radiation therapy
- DRUG Study Drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-08-10 |
| Est. Completion | 2019-02-20 |
| Phase | Phase 2 |
Why NCT02538471 stopped before completion
NCT02538471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiation therapy is the first listed.
NCT02538471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02538471 about?
NCT02538471 is a clinical study titled "LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer". Patients with metastatic breast cancer receiving at least one single agent chemotherapy and demonstrating stable disease or disease progression at two consecutive clinical/radiological assessments (at an interval of at least 2 weeks). Transforming growth factor-beta (TGFΒ) blockade will enhance res...
What is the current status of trial NCT02538471?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-08-10. Estimated completion is 2019-02-20.
What interventions are being tested in trial NCT02538471?
The interventions under investigation include: Radiation therapy (RADIATION), Study Drug (DRUG).
Who is sponsoring clinical trial NCT02538471?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02538471's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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
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