Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 213 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565083
The ClinicalTrials.gov registry entry for NCT01565083 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01565083 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.