NCT05861271

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,008 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Stage I

Interventions

Type	Name	Description
DRUG	Capecitabine，Pyrotinib	Pyrotinib and Capecitabine for half a year

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2023-05-16
• Last updated: 2024-03-22

Locations

1 site across 1 country: China