RecruitingPhase 2NCT05861271

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Sponsor

Fudan University

Enrollment

1,008 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage I

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of pyrotinib (a targeted HER2 drug) and capecitabine (a chemotherapy pill) as a treatment after surgery in women with very early-stage HER2-positive breast cancer where the invasive tumor is extremely small (1 mm or less). **You may be eligible if...** - You are a woman between 18 and 70 years old - You have had surgery for early breast cancer with a very tiny invasive component (no more than 1mm) and no lymph node spread - Your cancer is HER2-positive (confirmed by lab testing) - You are in good general health with adequate blood counts, liver, kidney, and heart function - You have no history of other cancers in the past 5 years **You may NOT be eligible if...** - Your invasive tumor is larger than 1mm - You have had a prior serious heart condition or your heart function is reduced - You are pregnant or breastfeeding - You have poor organ function that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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