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NCT01419197 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
- 20
- Study locations
NCT01419197 is a Phase 3 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 602 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT01419197, a Phase 3 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
Conditions Studied
Interventions
- DRUG Trastuzumab emtansine
- DRUG Treatment of physician's choice
Study Locations (20)
California
- - Hayward
- - Highland
- - Oakland
- - Roseville
- - Sacramento
- - San Diego
- - San Francisco
- - San Jose
- - Santa Clara
- - South San Francisco
- - Stockton
- - Vallejo
- - Walnut Creek
- - West Hollywood
Arizona
- - Tucson
Arkansas
- - Hot Springs
Colorado
- - Denver
Connecticut
- - Trumbull
Delaware
- - Newark
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419197
The ClinicalTrials.gov registry entry for NCT01419197 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (79% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab emtansine is the first listed.
NCT01419197 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01419197 about?
NCT01419197 is a clinical study titled "A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy". This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor recep...
What is the current status of trial NCT01419197?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2011-09. Estimated completion is 2015-08.
What conditions does trial NCT01419197 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01419197?
The interventions under investigation include: Trastuzumab emtansine (DRUG), Treatment of physician's choice (DRUG).
Who is sponsoring clinical trial NCT01419197?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419197 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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