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NCT03979508 · ClinicalTrials.gov registry record · Phase 2
Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03979508: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT03979508 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03979508, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery (resectable) and does not respond to treatment with chemotherapy alone, or in combination with pembrolizumab. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
A Simon optimum two stage phase II clinical trial design was chosen to test the null hypothesis that the rate of conversion to post-abemaciclib CD8/FOXP3 ratio of 1.6 or more is =\< 5% against the alternative that rate of conversion to post-abemaciclib CD8/FOXP3 ratio of 1.6 or more is \>= 20% with the target probability of a type I error and probability of a type II error set to 0.10. The probability of terminating after the first stage is 0.736, if the null hypothesis is true. A 90% confidence
Interventions
- DRUG Abemaciclib
- PROCEDURE Therapeutic Conventional Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2024-12-26 |
| Phase | Phase 2 |
Why NCT03979508 stopped before completion
NCT03979508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.
NCT03979508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03979508 about?
NCT03979508 is a clinical study titled "Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer". This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery (resectable) and does not respond to treatment with chemotherapy alone, or in combination with pembrolizumab. Abemaciclib may stop the growth of cancer cells ...
What is the current status of trial NCT03979508?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2020-01-10. Estimated completion is 2024-12-26.
What interventions are being tested in trial NCT03979508?
The interventions under investigation include: Abemaciclib (DRUG), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03979508?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03979508's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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