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RECRUITING
NCT05861271
PHASE2

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1008

Start Date

2023-06-01

Completion Date

2028-07-01

Last Updated

2024-03-22

Healthy Volunteers

No

Interventions

DRUG

Capecitabine,Pyrotinib

Pyrotinib and Capecitabine for half a year

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China