drugset / Trial / NCT04539938

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

NCT04539938

Phase 2 Completed 70 enrolled Pfizer
NaSingle-groupOpen-labelTreatment

Summary

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

Timeline

Start
2020-12-01
Primary completion
2024-07-15
Completion
2025-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg
Subject Tucatinib Small molecule 300 mg Oral