Breast Cancer
Conditions
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
Interventions
DRUGPyrotinib
400mg administered as continuous oral once daily from the first day of the study
DRUGEpirubicin
90mg/m\^2 d1 iv Q2W for 4 cycles
DRUGCyclophosphamide
600 mg/m\^2 d1 iv Q2W for 4 cycles
DRUGTaxanes
Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
BIOLOGICALTrastuzumab
the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female breast cancer patients at the age of \>= 18 years and \<= 70 years who received first treatment； 2. 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)； 3. 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； 4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1； 5. 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%; 6. 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; 7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion criteria
1. Known history of hypersensitivity to pyrotinib or any of it components; 2. 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); 3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; 4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; 5. Patients with severe heart disease or discomfort who cannot be treated; 6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; 7. Pregnant or lactating women; 8. Less than 4 weeks from the last clinical trial; 9. Patients participating in other clinical trials at the same time 10. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tpCR | immediately after surgery | It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | 2 years | Baseline to measured stable disease |
| Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause | 3 years | Baseline to measured date of recurrence or death from any cause |
| bpCR | immediately after surgery | After neoadjuvant chemotherapy and surgery, breast was free of any invasive cancer |
| Adverse Events rate | 1-year | Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0 |
Countries
China
Outcome results
None listed