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NCT02774681 · ClinicalTrials.gov registry record · Phase 2
Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT02774681: Clinical Trial Phase 2 study, sponsored by Northwestern University.
NCT02774681 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02774681, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as HER2 positive breast cancer. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.
Primary Outcome
Assess the Radiographic Response Rate (RRR) in the CNS by modified Response Assessment in Neuro-Oncology Criteria Brain Metastasis (modifiedRANO-BM). Maximum response prior to disease progression will be used. In General: Complete Response : Disappearance of all lesions Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to
Interventions
- DRUG Palbociclib
- PROCEDURE Cognitive Assessment
- BIOLOGICAL Trastuzumab
- PROCEDURE Quality-of-Life Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2020-02-16 |
| Phase | Phase 2 |
Why NCT02774681 stopped before completion
NCT02774681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which Palbociclib is the first listed.
NCT02774681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02774681 about?
NCT02774681 is a clinical study titled "Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis". The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that has been shown to stop cancer c...
What is the current status of trial NCT02774681?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2016-08-31. Estimated completion is 2020-02-16.
What interventions are being tested in trial NCT02774681?
The interventions under investigation include: Palbociclib (DRUG), Cognitive Assessment (PROCEDURE), Trastuzumab (BIOLOGICAL), Quality-of-Life Assessment (PROCEDURE).
Who is sponsoring clinical trial NCT02774681?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02774681's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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