Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Launched by RENJI HOSPITAL · Feb 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pyrotinib to see if it can help reduce the chances of breast cancer coming back in women who have already received treatment. Specifically, it focuses on women with a type of breast cancer known as HER2-positive, who still have some cancer left after their initial treatment with chemotherapy and targeted therapy. The trial aims to understand if adding pyrotinib to the standard treatment can provide additional benefits.

To participate in this trial, women must be between 18 and 70 years old, have been diagnosed with early-stage HER2-positive breast cancer, and need to have completed their initial treatments within the last year. They should also have some remaining invasive cancer found during surgery. Participants will receive pyrotinib and will be monitored for its effectiveness and safety. It's important to know that this study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they meet the criteria and to understand what being part of the trial entails.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female, Aged ≥18 and ≤70 years;
• • Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
• • Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
• • Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
• • Been or being treated for early breast cancer with standard of care duration of trastuzumab;
• • Adjuvant treatment regimen needs to be determined before randomization;
• • Duration from Random time to the last use of trastuzumab≤1 year.
• • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
• • Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: \< 470 ms
• • Signed informed consent form (ICF) .
• Exclusion Criteria:
• • Metastatic disease (Stage IV) ;
• • Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
• • Progressive disease during neoadjuvant therapy;
• • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
• • Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
• • Less than 4 weeks from the last clinical trial;
• • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
• • Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
• • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
• • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.