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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: Completed Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.
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 |
What the finished NCT01419197 record still lists
NCT01419197 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (79% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01419197's enrollment target sits among peer trials
602 176th of 1224 higher than 1,049 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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