ATEMPT 2.0: Adjuvant T-DM1 vs TH
NCT04893109 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2026-04-24
Summary
This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.
The name of the study drugs involved are:
* Trastuzumab-emtansine (T-DM1, Kadcyla)
* Trastuzumab SC (Herceptin Hylecta)
* Paclitaxel
Conditions
Interventions
- DRUG
-
intravenous infusion
- DRUG
-
trastuzumab-emtansine
intravenous infusion
- DRUG
-
Trastuzumab SC
Muscular injection
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Sara Tolaney, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-16
- Primary Completion
- 2026-11-01
- Completion
- 2028-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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