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NCT02389764 · ClinicalTrials.gov registry record · Phase 2
Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02389764: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02389764 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389764, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied. This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung disease. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
Clinical benefit defined as participants who achieve CR or PR within 3 months post-treatment, or participants who experience SD for at least three months post-treatment. Clinical benefit rate determined by RECIST 1.1 version." PATHOLOGICAL CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes. PR is defined as 30% or greater decrease for a minimum of 4 weeks in the measurable lesion as determined by the product of the perpendicular diameters of the l
Interventions
- BEHAVIORAL Phone Call
- DRUG BIBF 1120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-06-22 |
| Est. Completion | 2019-06-08 |
| Phase | Phase 2 |
Why NCT02389764 stopped before completion
NCT02389764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Phone Call is the first listed.
NCT02389764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02389764 about?
NCT02389764 is a clinical study titled "Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)". The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied. This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung ...
What is the current status of trial NCT02389764?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-06-22. Estimated completion is 2019-06-08.
What interventions are being tested in trial NCT02389764?
The interventions under investigation include: Phone Call (BEHAVIORAL), BIBF 1120 (DRUG).
Who is sponsoring clinical trial NCT02389764?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02389764's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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