triple-negative breast cancer
Conditions
Interventions
Experiment Group:Fluzoparil+Paclitaxel (5-8 cycle, 4 cycles)
Control Group:Fluzoparil+Paclitaxel (3-8 cycle, 6 cycles)
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, female, newly treated breast cancer patients; 2. According to the definition of the latest ASCO/CAP guidelines, early or locally advanced invasive triple-negative breast cancer confirmed by histopathology T >= 2cm; 3. ECOG score 0-1; 4. According to RECIST version 1.1, there is at least one evaluable target lesion; 5. Adequate organ function, subject shall meet the following laboratory criteria: (1) Blood routine 1) Absolute value of neutrophils (ANC) >= 1.5x10^9/L (without the use of granulocyte colony-stimulating factor in the last 14 days before the trial); 2) Platelets >= 100 x 10^9/L (without blood transfusion in the last 14 days before the trial); 3) Hemoglobin >= 90 g/L; (2) Blood chemistry 1) Total bilirubin = 50%; 2) 12-lead ECG: 1°QT interval, female < 470 ms; 6. Women of childbearing age must have a serological pregnancy study within 7 days before the study and the results are negative. Women of reproductive age subjects must agree to use a highly effective method of contraception during the study period and for three months after the last dose of the study drug; 7. Subjects voluntarily join the study, sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Tumor-related symptoms and treatment (1) Patients with metastatic breast cancer or bilateral breast cancer; (2) Patients with inflammatory breast cancer; (3) Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy or tumor embolization; (4) Have received PARP inhibitor treatment in the past; 2. Concomitant disease/medical history (1)Other malignant tumors in the past; have received any systemic anti-tumor treatment or local treatment (including surgery and radiotherapy) for malignant tumors, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; (2)Major surgical operations not related to breast cancer were received in the 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations (tissue biopsy required for diagnosis and central venous catheter placement via peripheral venous puncture [PICC] is allowed); (3)Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/mL; hepatitis C, hepatitis C antibody positive And HCV-RNA is higher than the detection limit of the analysis method) or combined with hepatitis B and C co-infection; autoimmune hepatitis; (4)Severe infections, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. 4 weeks before the first administration; or CTCAE >= level 2 activities requiring systemic antibiotic treatment 2 weeks before the first administration Sexual infection, or fever of unknown origin during the screening period/before the first administration >38.5°C (according to the judgment of the investigator, fever due to tumor can be included in the group); (5) Subjects who have previously or planned to receive allogeneic bone marrow transplantation or solid organ transplantation (6) Severe heart disease or discomfort, including but not limited to the following diseases: 1) Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II Second degree atrioventricular block or third degree atrioventricular block); 3) Angina pectoris requiring anti-angina pectoris medication; 4) Clinically significant heart valve disease; 5) ECG shows transmural myocardial infarction; 6) Poor hypertension control (systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg); 3. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire test period; 4. Have a clear history of neurological or mental disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcohol or drug abuse; 5. The researcher believes that the patient is not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual cancer burden;Objective response rate;Event free survival;Overall survival;Clinical safety; | — |
Countries
China
Contacts
Public ContactLiu Xiaoan
Outcome results
None listed