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NCT01565083 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 213
- Enrollment target
NCT01565083: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01565083 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 213 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565083, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 213 participants
- Enrollment target
Study Summary
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.
Primary Outcome
Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis \[SA\] of at least (\>/=) 15 millimeter \[mm\]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal les
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- DRUG Vinorelbine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01565083 record still lists
NCT01565083 is an interventional study that assigns participants to a tested intervention. The registered 213 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 (60% higher).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01565083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565083 about?
NCT01565083 is a clinical study titled "A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer". This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab...
What is the current status of trial NCT01565083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 213 participants. The study started on 2012-04. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01565083?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT01565083?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01565083's enrollment target sits among peer trials
213 290th of 2000 higher than 1,711 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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