drugset / Trial / NCT04246502

Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

NCT04246502

Phase 2 Unknown 200 enrolled Shandong Cancer Hospital and Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Timeline

Start
2020-01
Primary completion
2022-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pertuzumab Monoclonal antibody
Subject Pyrotinib Small molecule 400 mg Oral
Comparator Trastuzumab Monoclonal antibody
Comparator Capecitabine Small molecule

Indications