AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer

RecruitingPhase 2Ages 18 Years - 65 YearsFemaleHebei Medical University Fourth Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer. Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete respon

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ100 g/L. * Absolute neutrophil count โ‰ฅ1.5 ร— 10\^9/L. * Platelet count โ‰ฅ100 ร— 10\^9/L. * Total bilirubin โ‰ค1 ร— upper limit of normal (ULN). * Alanine aminotransferase and aspartate aminotransferase โ‰ค1.5 ร— ULN. * Alkaline phosphatase โ‰ค2.5 ร— ULN. * Blood urea nitrogen and serum creatinine โ‰ค1.5 ร— ULN. * Left ventricular ejection fraction โ‰ฅ55% 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.
๐Ÿ’Š

What it tests

  • Pyrotinib Maleate
  • Trastuzumab (H, 8mg/kg
  • pegylated liposomal doxorubicin hydrochloride
  • Cyclophosphamide
  • Paclitaxel for Injection Albumin Bound
๐Ÿ“

Where

1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy