Using pyrotinib to prevent recurrence 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

This study is testing if the drug pyrotinib can help prevent breast cancer from coming back in women who have already been treated for HER2-positive breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: trastuzumab, pyrotinib, lapatinib, neratinib, chemotherapy, pertuzumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04254263 on ClinicalTrials.gov

What this trial studies

This interventional phase 3 study evaluates the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer following neoadjuvant chemotherapy and anti-HER2 therapy. It is a prospective, randomized, multicenter, open-label trial that aims to determine if pyrotinib can further reduce the risk of cancer recurrence compared to standard adjuvant treatment with trastuzumab, with or without pertuzumab. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 70 with histologically confirmed invasive HER2-positive breast cancer who have completed neoadjuvant therapy and have residual invasive disease.

Not a fit: Patients with early-stage breast cancer who do not have residual invasive disease after neoadjuvant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of cancer recurrence in patients with HER-2 positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in targeting HER2-positive breast cancer, suggesting potential for success in this trial.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jinsong Lu — RenJi Hospital
• Study coordinator: Wenjin Yin

Conditions Locally Advanced Breast Cancer