drugset / Trial / NCT05861271

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

NCT05861271 ↗

Phase 2 Recruiting 1008 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.

Timeline

Start
2023-06-01
Primary completion
2026-07-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 500 mg Oral
Subject Pyrotinib Small molecule 400 mg Oral

Indications