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NCT00934856 · ClinicalTrials.gov registry record · Phase 1
A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00934856 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 98 participants.
The verdict
NCT00934856, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.
Interventions
- DRUG Docetaxel
- DRUG Trastuzumab emtansine
- DRUG Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00934856
The ClinicalTrials.gov registry entry for NCT00934856 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 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 Docetaxel is the first listed.
NCT00934856 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00934856 about?
NCT00934856 is a clinical study titled "A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer". This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with loc...
What is the current status of trial NCT00934856?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2009-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00934856?
The interventions under investigation include: Docetaxel (DRUG), Trastuzumab emtansine (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT00934856?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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