Real world research for Pingxiao capsule to treat triple negative breast cancer research
- Conditions
- Breast cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Triple negative breast cancer confirmed by histology or cytology;
2. The patients agreed to be treated;
3. They were 18-75 years old;
4. The expected survival time was more than 12 weeks;
5. ECoG status score was 0-2;
6. According to RECIST 1.1, there was at least one measurable lesion;
7. The organ function level must meet the following requirements:
Hematological indexes: absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, hemoglobin >= 9.0 g / dl (can be maintained by blood transfusion);
Liver function: total bilirubin <= 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase <= 2.5 times the upper limit of normal value, if there is intrahepatic transaminase <= 5 times the upper limit of normal value;
Renal function: creatinine <= 1.25 times the upper limit of normal value, and creatinine clearance rate >= 60ml / min;
8. Women of childbearing age must have urine pregnancy test within 7 days before treatment, and the result is negative, and they are not in lactation
During the lactation period, the male should agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial period and within 8 weeks after the last administration of the trial drug;
9. Ability to comply with research and follow-up procedures;
10. Patients have the ability to understand and sign informed consent voluntarily.
Subjects who meet any of the following exclusion criteria are not eligible to participate in the study:
1. Patients who have had any systemic anti-cancer treatment, including cytotoxic drug therapy, targeted drug therapy, experimental treatment, adjuvant chemotherapy or neoadjuvant chemotherapy (but patients with recurrence after stopping for more than 6 months can be selected);
2. The target focus was treated by radiotherapy or radio frequency;
3. Combination of phenytoin, carbamazepine, rifampin, barbital or St. John's grass;
4. Other malignant tumors have been developed in the past 5 years, except for the cured basal cell carcinoma, cervical in situ cancer, surgical treatment of localized prostate cancer or surgical resection of breast duct carcinoma in situ;
5. The patient has one or more of the following conditions:
Patients with symptomatic central nervous system metastasis or spinal cord compression;
A large number of pleural effusion or pericardial effusion;
Any unstable systemic disease (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases);
It is impossible to accept oral administration, need high energy nutrition in vein, and have performed operations and activities that have previously affected absorption;
Patients with peptic ulcer and chronic diarrhea;
It is known that it is allergic to relevant components of Pingxiao capsule;
6. The researchers believe that subjects may not be able to complete the study or may not comply with the requirements of the study (for management reasons or other reasons).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method