drugset / Trial / NCT04733118

Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer

NCT04733118

Phase 2 Active not recruiting 393 enrolled MedSIR Hoffmann-La Roche · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer.

Timeline

Start
2021-08-05
Primary completion
2027-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody Subcutaneous
Subject Trastuzumab Monoclonal antibody Subcutaneous
Subject Trastuzumab emtansine Other / unclassified

Indications