Breast Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female initial treatment patients aged>=18 years and =55%. 4) 12 lead electrocardiogram The QT interval (QTcF) corrected by the Fridericia method is less than 470 milliseconds. 6. The researcher determines that they can comply with the research protocol; 7. Understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Have received previous anti-tumor treatment or radiation therapy for any malignant tumor; 4. Have a history of other malignant tumors within the past 5 years prior to signing the informed consent form; 5. Have received or are receiving targeted, immunotherapy or traditional Chinese patent medicines and simple preparations with clear anti-tumor indications for the disease; 6. The patient has undergone major surgical procedures within 4 weeks prior to enrollment and has not fully recovered from such surgical procedures; 7. Used any clinical trial drug within 4 weeks prior to enrollment; 8. Those who are HIV positive, anti HCV positive, HCV RNA positive and syphilis antibody positive before enrollment, hepatitis B surface antigen positive and HBV DNA quantitative test are determined as positive by the researcher according to local standards; 9. Prior to enrollment, there was severe heart disease or discomfort; 10. Allergic to any investigational drug or its components or excipients, or allergic to benzyl alcohol; 11. Breastfeeding women; 12. Bilateral breast cancer; 13. Diabetic patients with peripheral neuropathy; 14. According to the researcher's judgment, the subject may have complications that may interfere with the research plan or other situations that are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total pathological complete response (tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival;objective response rate;breast pathological complete response;safety; | — |
Countries
China
Contacts
The 2nd Affiliated Hospital of Harbin Medical University