RecruitingPhase 2NCT05834764

Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

188 participants

Start Date

Apr 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing pyrotinib — a targeted oral drug that blocks HER2 and related proteins — as an additional treatment for people with HER2-positive early breast cancer who still had remaining cancer after standard pre-surgery chemo plus trastuzumab/pertuzumab (or T-DM1). These are patients considered high risk because their cancer did not fully disappear with standard therapy. **You may be eligible if...** - You have HER2-positive early or locally advanced breast cancer confirmed by biopsy - Your cancer did not completely disappear after standard pre-surgery treatment (no pathologic complete response) - You had lymph node involvement after surgery - You have already completed standard trastuzumab-based treatment - You are 18–75 years old with good overall health **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (stage IV or inflammatory breast cancer) - You have had another cancer in the past - You have serious heart disease or uncontrolled high blood pressure - You have significant gastrointestinal disease that causes chronic diarrhea - You are unable to swallow tablets 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 after anti-HER2 therapy(Trastuzumab combined with Pertuzumab or T-DM1)


Locations(1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05834764


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