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NCT02213042 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02213042: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02213042 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02213042, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a post-approval commitment with regulatory authorities. It was designed to evaluate whether treatment with Dual blockade promoted changes to biomarkers associated with immunomodulation.
Primary Outcome
Evaluate changes in biomarkers associated with immunomodulation between pre-treatment biopsy and disease progression biopsy within each arm. Biomarker analysis was performed using an mRNA gene expression panel derived from Nanostring platform in a total of 20 subjects who received the study treatment as per the study design and with baseline tumor biopsies available. For the selected biomarkers associated with immunomodulation, the median fold changes of gene expression level and 95% confidence
Interventions
- BIOLOGICAL Trastuzumab
- DRUG Lapatinib
- DRUG Aromatase Inhibitors (AIs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2014-10-24 |
| Est. Completion | 2020-06-04 |
| Phase | Phase 2 |
Why NCT02213042 stopped before completion
NCT02213042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT02213042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02213042 about?
NCT02213042 is a clinical study titled "Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer". This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a po...
What is the current status of trial NCT02213042?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2014-10-24. Estimated completion is 2020-06-04.
What interventions are being tested in trial NCT02213042?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Lapatinib (DRUG), Aromatase Inhibitors (AIs) (DRUG).
Who is sponsoring clinical trial NCT02213042?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02213042's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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