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
Public ClinicalTrials.gov record NCT01419197. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01419197
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 602 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Feb 2013 (Actual)
- Completion
- Aug 2015 (Actual)
- Last update posted
- Oct 12, 2016
2011 – 2015
United States locations
- U.S. sites
- 59
- U.S. states
- 32
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Tucson | Arizona | 85704 | — |
| Not listed | Hot Springs | Arkansas | 71913 | — |
| Not listed | Hayward | California | 94545 | — |
| Not listed | Highland | California | 92346 | — |
| Not listed | Oakland | California | 94611 | — |
| Not listed | Roseville | California | 95661 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | San Francisco | California | 94115 | — |
| Not listed | San Jose | California | 95119 | — |
| Not listed | Santa Clara | California | 95051 | — |
| Not listed | South San Francisco | California | 94080 | — |
| Not listed | Stockton | California | 95204 | — |
| Not listed | Vallejo | California | 94589 | — |
| Not listed | Walnut Creek | California | 94596 | — |
| Not listed | West Hollywood | California | 90048 | — |
| Not listed | Denver | Colorado | 80220 | — |
| Not listed | Trumbull | Connecticut | 06611 | — |
| Not listed | Newark | Delaware | 19713 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Coral Springs | Florida | 33065 | — |
| Not listed | Deerfield Beach | Florida | 33442 | — |
| Not listed | Fort Myers | Florida | 33905 | — |
| Not listed | Jacksonville | Florida | 32256 | — |
| Not listed | Plantation | Florida | 33324 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Post Falls | Idaho | 83854 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Maywood | Illinois | 60153 | — |
| Not listed | Fort Wayne | Indiana | 46815 | — |
| Not listed | Sioux City | Iowa | 51101 | — |
| Not listed | Wichita | Kansas | 67214-3728 | — |
| Not listed | Scarborough | Maine | 04074 | — |
| Not listed | Bethesda | Maryland | 20817 | — |
| Not listed | Columbia | Maryland | 21044 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Boston | Massachusetts | 02130 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | Minneapolis | Minnesota | 55455 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | New Brunswick | New Jersey | 08901 | — |
| Not listed | Lake Success | New York | 11042 | — |
| Not listed | The Bronx | New York | 10467 | — |
| Not listed | Charlotte | North Carolina | 28203 | — |
| Not listed | Columbus | Ohio | 43219 | — |
| Not listed | Portland | Oregon | 97210 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Charleston | South Carolina | 29414 | — |
| Not listed | Chattanooga | Tennessee | 37404 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Richmond | Virginia | 23230 | — |
| Not listed | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 125 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01419197, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 12, 2016 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01419197 live on ClinicalTrials.gov.