Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
Eligibility Criteria
Inclusion
- Female breast cancer patients at the age of \>= 18 years and \<= 70 years who received first treatment；
- Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
- According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
- The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
- The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
- Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
- A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion
- Known history of hypersensitivity to pyrotinib or any of it components;
- Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
- Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
- Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
- Patients with severe heart disease or discomfort who cannot be treated;
- The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
- Pregnant or lactating women;
- Less than 4 weeks from the last clinical trial;
- Patients participating in other clinical trials at the same time
- The researchers think inappropriate.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2026
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04290793
Start Date
March 1 2020
End Date
December 10 2026
Last Update
January 7 2026
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China