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NCT01934894 · ClinicalTrials.gov registry record · Phase 2
Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases
A Phase 2 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01934894: Clinical Trial Phase 2 study, sponsored by SCRI Development Innovations.
NCT01934894 is a Phase 2 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 11 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
NCT01934894, a Phase 2 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of the study will determine the optimal dose of the cabazitaxel/lapatinib combination to administer to patients. After determining the optimal dose, patients will continue treatment with cabazitaxel and lapatinib to assess response to treatment with these agents.
Primary Outcome
The number of patients with Complete and Partial Response (CR+PR) of CNS lesions assessed per modified RECIST Criteria for Evaluation of Intracranial Disease. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.
Interventions
- DRUG lapatinib
- DRUG cabazitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
Why NCT01934894 stopped before completion
NCT01934894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 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 lapatinib is the first listed.
NCT01934894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934894 about?
NCT01934894 is a clinical study titled "Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases". This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of the study will determine the optimal dose of the cabazitaxel/lapatinib combination to administer to patients. After ...
What is the current status of trial NCT01934894?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2014-05. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01934894?
The interventions under investigation include: lapatinib (DRUG), cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT01934894?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01934894's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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