Using pyrotinib to prevent recurrence in HER-2 positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: followroad@163.com
• Phone: 86(21)68385569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

  This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07393425

• Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy

  This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.