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NCT01982448 · ClinicalTrials.gov registry record · Phase 2
Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT01982448: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01982448 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 147 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
NCT01982448, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
This is a phase II study randomizing patients with stage I with T1 \> 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to preoperative chemotherapy.
Primary Outcome
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The posi
Interventions
- DRUG Cisplatin
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2014-04 |
| Est. Completion | 2020-08 |
| Phase | Phase 2 |
What the finished NCT01982448 record still lists
NCT01982448 is an interventional study that assigns participants to a tested intervention. The registered 147 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 2 interventions - of which Cisplatin is the first listed.
NCT01982448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01982448 about?
NCT01982448 is a clinical study titled "Cisplatin vs Paclitaxel for Triple Negative Breast Cancer". This is a phase II study randomizing patients with stage I with T1 \> 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic r...
What is the current status of trial NCT01982448?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2014-04. Estimated completion is 2020-08.
What interventions are being tested in trial NCT01982448?
The interventions under investigation include: Cisplatin (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01982448?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01982448's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 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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