Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early 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 is a single-arm, multicenter Phase 2 trial evaluating the safety and activity of a neoadjuvant regimen that includes Pyrotinib and Trastuzumab with pegylated liposomal doxorubicin and cyclophosphamide, followed by paclitaxel for HER2-positive early breast cancer. Participants will receive eight cycles of neoadjuvant therapy, with the first four cycles including Pyrotinib daily and Trastuzumab every three weeks, alongside liposomal doxorubicin and cyclophosphamide, and the last four cycles consisting of albumin-bound paclitaxel. The primary endpoint is total pathological complete response, with secondary endpoints including breast and lymph node pathological complete responses, objective response rate, event-free survival, distant disease-free survival, and overall survival. The study is conducted at The Fourth Hospital of Hebei Medical University in Shijiazhuang, with Hebei Medical University Fourth Hospital as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients aged 18 to 65 years.
* Patients with previously untreated invasive breast cancer confirmed by pathological examination.
* HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.
* Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
* At least one measurable lesion according to RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function, meeting all of the following criteria:
* Hemoglobin ≥100 g/L.
* Absolute neutrophil count ≥1.5 × 10\^9/L.
* Platelet count ≥100 × 10\^9/L.
* Total bilirubin ≤1 × upper limit of normal (ULN).
* Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.
* Alkaline phosphatase ≤2.5 × ULN.
* Blood urea nitrogen and serum creatinine ≤1.5 × ULN.
* Left ventricular ejection fraction ≥55% by echocardiography.
* Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of study treatment.
* Patients must voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria:

* Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.
* Concurrent receipt of any other anti-tumor therapy.
* Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
* Stage IV breast cancer.
* Breast cancer not confirmed by pathological examination.
* History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.
* Severe dysfunction of major organs, including the heart, liver, or kidney.
* Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.
* Participation in another drug clinical trial within 4 weeks before enrollment.
* Known history of allergy to any component of the study treatment.
* History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
* History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.
* Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.
* Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.
* Clear history of neurological or psychiatric disorders, including epilepsy or dementia.
* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

Where it's running

• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Principal investigator: Zhenchuan Song — Hebei Medical University Fourth Hospital
• Study coordinator: Zhenchuan Song, MD
• Email: songzhch@hotmail.com
• Phone: 18531117857

Similar studies

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

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

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

• Using pyrotinib and trastuzumab for maintenance therapy in HER2-positive breast cancer

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• Comparing two treatment regimens for HER-2 positive breast cancer

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• Chemotherapy sensitivity-guided Culmerciclib combo for HR+/HER2- breast cancer before surgery

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• 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

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.