breast cancer
Conditions
Interventions
control group:placebo
Sponsors
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of TCM
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be female, aged 18 to 70 years old. 2. Pathologically confirmed as primary invasive breast cancer by core needle biopsy. All patients had measurable tumor lesions (At least one measurable lesion) before treatment and the clinical staging was IIA ~ IIIC (AJCC 9th edition). 3. Not received treatment for breast cancer previously. 4. ECOG Score 0 to 2 ; 5. The normal range of hematologic examination and blood biochemical examination before treatment. 6. No serious impairment of cardiac, hepatic and renal functions. 7. Patients with good compliance. 8. Signed written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. Pregnant (serum ß-HCG test) or lactating women; 2. Distant Metastasis of breast cancer was confirmed; 3. Patients with evidence of sensory or motor neurone disease; 4. There are clear signs of cardiovascular disease, severe co-morbidity or active infection, including known HIV infection. 5. Any previous or concurrent primary malignancy; 6. Allergic to research drugs or their excipients; 7. Cannot participant in the study due to any reasons such as language issues, geometrically unable to follow-up, etc.; 8. Other conditions or diseases that may result in significant risk to the patients as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| expression of CSN5;pathological complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) and time to reponse (TTR);disease free survival (DFS) and overall survival (OS);quality of life;serum immune-inflammation markers; | — |
Countries
China
Contacts
Public ContactJi Yajie
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed