Breast cancer
Conditions
Interventions
Observation group:Neoadjuvant chemotherapy + Shenling Lianxia granules
Control Group:Neoadjuvant chemotherapy + Shenling Lianxia Granules simulator
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 75 years old; 2. Patients with a histopathological and immunohistochemical diagnosis of primary stage II-III triple-negative breast cancer; 3. Patientsanthracycline-based combined with cyclophosphamide followed by taxane-based neoadjuvant chemotherapy; 4. Patients with at least one measurable tumor lesion according to the RECIST 1.1 criteria; 5. Patients with an ECOG performance status of 0-1; 6. Patients with an expected survival of more than 6 months; 7. Patients who provide informed consent and are able to comply with long-term follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with concurrent primary malignant tumors; 2. Subjects with bilateral breast cancer; 3. Pregnant or breastfeeding women; 4. Subjects with severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system diseases, or mental disorders, or severe organ dysfunction; 5. Subjects who have received any form of anti-tumor therapy (radiotherapy, chemotherapy, traditional Chinese medicine treatment, etc.) within the past month; 6. Subjects who have received traditional Chinese medicine treatment within the past three months; 7. Subjects with a history of alcohol abuse or drug dependence; 8. Subjects participating in other clinical studies.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate (CBR);Objective Remission Rate (ORR);Breast Cancer Miller-Payne (MP) Grading System;Residual Cancer Burden (RCB) Assessment;Peripheral Blood Lymphocyte Level;stromal tumor-infiltrating lymphocytes (sTILs);EORTC Quality of Life Questionnaire QLQ-C30 (Version 3.0); | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate; | — |
Countries
China
Contacts
Public ContactLiu Sheng
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Outcome results
None listed