HER2-positive Breast Cancer
Conditions
Brief summary
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.
Detailed description
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden scores.
Interventions
DRUGPyrotinib
Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin.In adjuvant therapy, pathological complete response patients receive pyrotinib time to one year, non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine time to one year，RCB≥2 were treated with Trastuzumab Emtansine combined with pertuzumab time to one year.
Sponsors
Nie Jianyun
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged ≥18 years and ≤75 years with newly treated breast cancer; 2. Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive); 3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0); 4. Eastern Cooperative Oncology Group score 0\ 1; 5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND); 6. If the major organs function normally, the following criteria are met: (1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.
Exclusion criteria
1. Known allergic history of the drug components of this protocol; 2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery; 4. Stage IV (metastatic) breast cancer patients; 5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 6. Serious heart disease or discomfort that cannot be treated; 7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 8. Pregnant or lactating women; 9. Patients with severe liver and kidney function diseases and blood system diseases; 10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Patients with poor compliance and refusal to cooperate with treatment; Patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival(EFS) | 3 year | Event Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total pathological complete response(tpCR) | 24 month | total pathological complete response |
Contacts
Primary ContactNie Jian Yun, Ph.D
Outcome results
None listed