RecruitingNCT06035016

Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer


Sponsor

Peking Union Medical College Hospital

Enrollment

300 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pyrotinib combined with capecitabine (a chemotherapy pill) helps prevent HER2-positive early-stage breast cancer from coming back after surgery, for patients who still have cancer remaining after their initial chemotherapy before surgery. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with HER2-positive breast cancer and have had surgery (mastectomy or breast-conserving surgery) within the past 90 days - Your lymph nodes were positive, or you had a tumor larger than 1 cm (or 0.5–1 cm with additional high-risk features) - You are in good physical health **You may NOT be eligible if...** - Your cancer has come back or spread to other parts of the body - You have previously been treated with other HER2-targeted oral drugs (like lapatinib, neratinib, or pyrotinib) - You have been diagnosed with another cancer in the past 5 years (except certain skin or cervical cancers) - You have been in another clinical trial in the past 4 weeks 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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Interventions

DRUGpyrotinib combined with Capecitabine

Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w

DRUGtreatment of physician's choice

Treatment of physician's choice


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06035016


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