Are there any kadcyla related clinical trials underway?

Current Kadcyla Trials in Progress

Kadcyla (ado-trastuzumab emtansine), an antibody-drug conjugate for HER2-positive breast cancer, has several active clinical trials testing it in new combinations or settings. As of late 2024, ClinicalTrials.gov lists over 20 recruiting or active (not yet recruiting) studies involving Kadcyla.1 These focus on expanding its use beyond approved indications like adjuvant therapy post-Herceptin and Taxol.

Trials Testing Kadcyla with Immunotherapies

Multiple Phase 3 trials combine Kadcyla with Keytruda (pembrolizumab).
- KATE3 (NCT04784715) evaluates Kadcyla plus Keytruda versus Kadcyla alone in high-risk, early-stage HER2-positive breast cancer after neoadjuvant therapy. Enrollment is ongoing with an estimated 1,500 patients.1
- Another Phase 3 (NCT05255653) pairs it with Keytruda in residual invasive disease post-neoadjuvant treatment.1

Smaller Phase 2 studies pair Kadcyla with other agents like tucatinib (NCT04539938) or sacituzumab govitecan (NCT05191050) for metastatic cases.1

Trials in Early-Stage or Metastatic Breast Cancer

• ADAPTcycle (NCT04840363), a Phase 3 trial, tests Kadcyla with endocrine therapy in HR-positive/HER2-positive early breast cancer.1
  
• For metastatic disease, a Phase 2 trial (NCT05738952) explores Kadcyla maintenance after first-line therapy.1
  
• Pediatric expansion: A Phase 1/2 study (NCT02979026) assesses Kadcyla in children with HER2-positive solid tumors.1
  
  

Trials in Other Cancers or Combinations

Kadcyla appears in trials for gastric cancer (NCT04618247, Phase 2 with ramucirumab) and biliary tract cancers (NCT05027443).1 A few explore it with PARP inhibitors like olaparib in HER2-low cancers (NCT05331111).1

When Do These Trials End and What Happens Next?

Most trials project primary completion between 2025 and 2028. For example, KATE3 estimates 2028 readout.2 Positive results could support new approvals; negative ones might limit expansion. Check ClinicalTrials.gov for updates, as statuses change frequently.1