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NCT01670500 · ClinicalTrials.gov registry record · Phase 2
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT01670500: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01670500 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670500, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.
Primary Outcome
Pathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms.
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- DRUG Doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2012-10 |
| Est. Completion | 2025-02-02 |
| Phase | Phase 2 |
What the finished NCT01670500 record still lists
NCT01670500 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01670500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01670500 about?
NCT01670500 is a clinical study titled "Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa". This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this sett...
What is the current status of trial NCT01670500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2012-10. Estimated completion is 2025-02-02.
What interventions are being tested in trial NCT01670500?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT01670500?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670500's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 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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