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NCT01185509 · ClinicalTrials.gov registry record · Phase 2
Trastuzumab and Vinorelbine in Advanced Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01185509: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01185509 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185509, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2. The drug combination of trastuzumab and vinorelbine is an effective treatment for patients with breast cancers that are positive for HER2. This trial seeks to determine if the combination can also benefit participants whose original breast cancer was HER2 negative but whose circulating tumor cells are HER2 positive.
Primary Outcome
ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absen
Interventions
- DRUG trastuzumab
- DRUG vinorelbine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-11 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
Why NCT01185509 stopped before completion
NCT01185509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT01185509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185509 about?
NCT01185509 is a clinical study titled "Trastuzumab and Vinorelbine in Advanced Breast Cancer". The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2. The drug combination of tr...
What is the current status of trial NCT01185509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-11. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01185509?
The interventions under investigation include: trastuzumab (DRUG), vinorelbine (DRUG).
Who is sponsoring clinical trial NCT01185509?
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 NCT01185509's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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