Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Locally Advanced Breast Cancer Clinical Trial

— ATP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254263
• Other study ID #: KY2019-070
• Status: Recruiting
• Phase: Phase 3
• Start date: December 16, 2019
• Est. completion date: August 2028

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Wenjin Yin
• Phone: 86(21)68385569
• Email: followroad[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: August 2028
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female, Aged =18 and =70 years;

• Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ?A-?) ;

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer

Intervention

Drug:
• pyrotinib
pyrotinib 400 mg, orally once daily for one year

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-free Survival (iDFS)	Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.	From randomization until time of event up to 2 years.
Secondary	Disease-free Survival (DFS)	Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause	From randomization until time of event up to 2 years
Secondary	Overall Survival (OS)	Overall survival is defined as the time from randomization to death from any cause.	From randomization until time of event up to 2 years