T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Official title

The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

Study identification

NCT ID

NCT04457596

Recruitment status

Active, not recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Enrollment

1,056 participants

Conditions and interventions

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

Mar 1, 2021

Primary completion

Jan 30, 2028

Completion

May 30, 2035

Last update posted

Oct 28, 2025

2021 – 2035

United States locations

U.S. sites

1160

U.S. states

49

U.S. cities

752

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 16 non-U.S. sites.