Breast Cancer
Conditions
Interventions
Huai-er Group:Standard neoadjuvant therapy combined with Huai'er granules
Control group:Standard neoadjuvant therapy only
Sponsors
Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of triple negative breast cancer: 1. ER (-), PR (-), HER2 (- or 1+), HER2 (2+and FISH negative); 2. Diagnosis should be based on core needle biopsy, for those with unresected masses. 2. Age: 18-70 years old. 3. ECOG = 1.5 * 10^9/L, platelet count >= 100 * 10^9/L (non transfusion status), hemoglobin >= 90 g/L (non transfusion status). 6. Voluntary participation in this study, good compliance, and signing of informed consent form.
Exclusion criteria
Exclusion criteria: 1. The tumor has been removed and cannot be evaluated. 2. Received treatment for other malignant tumors. 3. Having serious or poorly controlled basic diseases (cardiovascular and cerebrovascular diseases, diabetes, dysfunction of other important organs, etc.). 4. The combination of severe heart, liver, kidney, and endocrine system diseases has been determined by researchers to pose unacceptable safety risks and affect the patient's compliance with the study protocol. 5. Known to be allergic to research drugs. 6. Pregnancy and lactation, or planning to conceive during the study period. 7. Participated in and currently participating in other clinical studies within the past 3 months. 8. Poor compliance or other reasons deemed unsuitable by researchers for clinical trial participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactZhang Panshi
Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
Outcome results
None listed