Also known as: trastuzumab emtansine
T-DM1 is ado-trastuzumab emtansine, marketed as KADCYLA, a HER2-targeted antibody-drug conjugate with microtubule inhibitor payload activity used in HER2-positive metastatic and early breast cancer settings. It is indicated as single-agent therapy in previously treated metastatic disease and as adjuvant treatment in residual invasive disease after neoadjuvant therapy. U.S. initial approval was in 2013.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06968585 |
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06830889 |
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy |
RECRUITING | PHASE3 |
| NCT06439693 |
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer |
RECRUITING | PHASE2 |
| NCT06316531 |
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06265428 |
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05429684 |
Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer |
UNKNOWN | PHASE3 |
| NCT05288777 |
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer |
RECRUITING | PHASE2/PHASE3 |
| NCT04622319 |
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04398914 |
Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04158947 |
A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone |
UNKNOWN | PHASE2 |
