Clinical study on Yanghe Decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
- Conditions
- breast cancer
- Registration Number
- ITMCTR2000003712
- Lead Sponsor
- Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method expression of CSN5;pathological complete response (pCR);
- Secondary Outcome Measures
Name Time Method objective response rate (ORR) and time to reponse (TTR);disease free survival (DFS) and overall survival (OS);quality of life;serum immune-inflammation markers;