RecruitingPhase 3NCT04254263

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy


Sponsor

RenJi Hospital

Enrollment

316 participants

Start Date

Dec 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called pyrotinib (a targeted therapy) after completing standard treatment for HER2-positive early breast cancer can reduce the chances of the cancer coming back, particularly in women who still had cancer cells remaining after their pre-surgery chemotherapy. **You may be eligible if:** - You are a woman aged 18–70 with HER2-positive early breast cancer (Stage IIA–III) - You completed chemotherapy plus the drug trastuzumab before surgery - Cancer cells were still found in your breast or lymph nodes after surgery - You have already received or are receiving the standard duration of trastuzumab therapy - Your blood counts and organ function are adequate **You may NOT be eligible if:** - Your cancer had no remaining cells at the time of surgery (complete pathologic response) - You have had a recurrence or distant spread of disease - You have significant heart problems or other conditions making this 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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Interventions

DRUGpyrotinib

pyrotinib 400 mg, orally once daily for one year


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT04254263


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