breast cancer
Conditions
Interventions
Experimental group:neoadjuvant chemotherapy combined with Pyrotinib Maleat
Sponsors
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, female; 2. Primary invasive breast cancer was diagnosed by histopathology, except occult breast cancer, inflammatory breast cancer and eczema like cancer; 3. Hormone receptor was positive (definition: estrogen receptor = 1%, and / or progesterone receptor = 1%) and HER2 was low (definition: immunohistochemistry result was + + and in situ hybridization result was negative); 4. The tumor is greater than 2 cm, or between 1 cm and 2 cm (cT1c) with histopathological involved lymph nodes; 5. According to RECIST version 1.1, there is at least one evaluable target lesion; 6. ECOG physical condition score was 0-1; 7. LVEF = 55 % 8. Adequate bone marrow functional reserve: WBC = 3.0 x 10^9 / L, neutrophil count = 1.5 x 10^9 /L Platelet count = 100 x 10^9 /L Hemoglobin = 90 g / L; 9. Aspartate aminotransferase and alanine aminotransferase: = 2.5 × upper limit of normal, alkaline phosphatase: = 2.5 × upper limit of normal, blood total bilirubin: = 1.5 × upper limit of normal; serum creatinine: = 1.5 × upper limit of normal; 10. For premenopausal or non surgically sterilized women: consent to contraception during treatment and at least 7 months after the last administration during the study; 11. Be able to understand the research process, voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. IV stage (metastatic) breast cancer and bilateral breast cancer; 2. Patients who are known to be allergic to the active or other components of the study drug; 3. According to the judgment of the researchers, patients who need other anti-tumor treatments (except ovarian function inhibitors) during neoadjuvant therapy; 4. Patients with severe heart disease or discomfort who are not expected to tolerate chemotherapy include but are not limited to: (1) Fatal arrhythmia or higher grade atrioventricular block (type 2 [mobitz 2] atrioventricular block or third degree atrioventricular block); (2) Unstable angina; (3) Heart valve disease with clinical significance; (4) ECG showed transmural myocardial infarction; (5) Uncontrollable hypertension. 5. During the first 4 weeks of randomization, there was a major surgical procedure independent of breast cancer, or the patient had not yet fully recovered from such operation; 6. Severe or uncontrolled infections that may affect the treatment or outcome of the study, including but not limited to active hepatitis virus infection, HIV antibody positive, pulmonary infection, etc; 7. There was a history of other malignant tumors in the past 5 years (except for cervical carcinoma in situ or basal cell carcinoma of skin); 8. Patients with gastrointestinal diseases (especially long-term history of diarrhea and constipation); inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption; 9. The researchers believe that the patient has any other conditions that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual cancer burden 0/I rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Objective response rate;Breast conservation surgery rate;5-year disease-free survival;5-year overall survival;Exploratory biomarkers analysis; | — |
Countries
China
Contacts
Public ContactChang Gong
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Outcome results
None listed