Kadcyla Phase 3 Trials Participant Numbers
Kadcyla (ado-trastuzumab emtansine), approved for HER2-positive breast cancer, has key Phase 3 trials with these enrollment figures:
EMILIA trial (T-DM1 vs. lapatinib + capecitabine)
1,982 patients with advanced HER2-positive breast cancer.[1]
TH3RESA trial (T-DM1 vs. treatment of physician's choice)
602 patients with previously treated HER2-positive metastatic breast cancer.[1]
KATHERINE trial (adjuvant T-DM1 vs. adjuvant trastuzumab)
1,486 patients with residual invasive breast cancer after neoadjuvant therapy.[1]
How Do These Trials Compare in Size and Focus?
EMILIA, the pivotal trial for Kadcyla's initial approval, is the largest at nearly 2,000 participants, targeting second-line metastatic disease. KATHERINE, supporting adjuvant use, enrolled over 1,400 high-risk early-stage patients. TH3RESA, at 602, focused on heavily pretreated metastatic cases. Combined, these exceed 4,000 participants across approvals.[1][2]
What About Ongoing or Smaller Kadcyla Trials?
Ongoing trials vary:
- NCT01772472 (T-DM1 + pertuzumab): 106 participants (completed).[3]
- NCT03523572 (T-DM1 in early breast cancer): ~100 planned (recruiting).[3]
Phase 1/2 studies typically enroll 20-100 patients, like NCT00943670 (83 participants).[3] Check ClinicalTrials.gov for updates, as numbers can adjust.
When Were These Trials Conducted and What Do Results Show?
EMILIA ran 2010-2012, showing 30.9-month median survival vs. 25.1 months for control.[2] KATHERINE (2013-2015) reduced recurrence risk by 50%.[2] TH3RESA (2013) extended progression-free survival to 6.9 months.[2]
[1]: FDA Kadcyla Label
[2]: NEJM Publications (EMILIA/KATHERINE)
[3]: ClinicalTrials.gov Search for Kadcyla