Triple negative breast cancer
Conditions
Interventions
single arm:Tetrandrine tablets
Sponsors
Fangshan Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The following criteria must be met when entering the group: (1) Meet the diagnostic criteria for triple negative breast cancer; (2) the first option IV period or recurrent metastatic breast cancer, and is not suitable for surgery; (3) No chemotherapy drugs have been used in the past for recurrent and metastatic breast cancer (adjuvant/neoadjuvant therapy is allowed, and the last time of use should be >= 1 month before recurrence and metastasis); (4) Subjects have at least one measurable lesion (RECIST 1.1); (5) The ECOG score of the Eastern United States Oncology Cooperative group was 0 or 1; (6) The expected survival time is more than 6 months; (7) Age 18-70 (including 18 and 70) at the time of informed consent; (8) Participate in this clinical trial voluntarily, give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: Any of the following criteria is excluded: (1) Gemcitabine, carboplatin, cisplatin and Tetrandrine hydrochloride tablets were used before enrollment; (2) Received radiotherapy, biohormone therapy, endocrine therapy, targeted therapy, etc., within 4 weeks before enrollment; (3) Severe infection within 4 weeks before enrollment, or active infection within 2 weeks requires oral or intravenous antibiotic treatment; (4) Had received hematopoietic stimulator, such as colony stimulating factor and erythropoietin, etc. within 2 weeks before enrollment; (5) systemic corticosteroids (equivalent to >10 mg prednisone per day) or other immunosuppressive drugs were required within 2 weeks before enrollment or during the study period; (6) The adverse reactions failed to recover to CTCAE V5.0 grade score 1.5ULN; Glutamate aminotransferase (ALT) > 2.5ULN and/or aspartate aminotransferase (AST) > 2.5ULN; Serum creatinine (Scr) > 1.5ULN; (14) poorly controlled diabetes mellitus (the upper limit of normal reference value of HbA1c); (15) of hypertension but after treatment with drugs regulate blood pressure remains poorly controlled (poorly controlled systolic blood pressure or greater 150 MMHG and/or diastolic blood pressure, 90 MMHG or higher), New York, cardiac function class (NYHA) III and above, within 6 months prior to screening happened in unstable angina, myocardial infarction, or line within six months of coronary artery intervention treatment or vascular transplantation; (16) present with interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, radiation pneumonia, etc.; (17) Other malignant tumors (except cured cervical carcinoma in situ and basal cell carcinoma of skin) within 5 years before enrollment; (18) Having primary diseases and mental illness (including a history of mental illness or a family history of mental illness), including severe blood, liver, kidney, respiratory, digestive, nervous system and other diseases; (19) Suspected or proven history of alcohol or drug abuse; (20) Allergic constitution or history of severe allergy, especially allergy to experimental drugs and ingredients; (21) In pregnant or lactating women, subjects of childbearing age have pregnancy plans or are unwilling to use effective contraceptives from the screening period to 6 months after the study; (22) Participated in other clinical trials within 3 months prior to screening; (23) The investigator considered it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram;Pregnancy test;Hemoglobin a1c;Estrogen receptor;Progesterone receptor;human epidermalgrowth factor receptor-2,HER2;Tumor markers (CA15-3, CEA);Chest computed tomography (CT);Abdominal and pelvic CT or MRI;Head CT or MRI;Breast CT or MRI;Bone scan;Routine blood test;Urinary routine;liver function;renal function; | — |
Countries
China
Contacts
Public ContactPei Xiaohua
Outcome results
None listed