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

ClinicalTrials.gov ID: NCT01419197

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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 5, 2026, 6:04 PM EDT

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
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 602 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Trastuzumab emtansine Drug
Treatment of physician's choice Drug

Drug

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: Aug 31, 2011
Primary completion: Jan 31, 2013
Completion: Jul 31, 2015
Last update posted: Oct 11, 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 11, 2016 · Synced Sep 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01419197 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →