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NCT02124902 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT02124902: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT02124902 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124902, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study Summary
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis. Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
Primary Outcome
-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discon
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- PROCEDURE FDG-PET/MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2014-07-07 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
Why NCT02124902 stopped before completion
NCT02124902 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT02124902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124902 about?
NCT02124902 is a clinical study titled "Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity". This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be develop...
What is the current status of trial NCT02124902?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2014-07-07. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT02124902?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), FDG-PET/MR (PROCEDURE).
Who is sponsoring clinical trial NCT02124902?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124902's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 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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