Triple-negative breast cancer
Conditions
Interventions
Case series:Treatment with antinib combined with Paclitaxel for Injection (Albumin Bound) was performed
Sponsors
The Affiliated Hospital of Jiangnan University (The 4th people’s hospital of Wuxi City)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18 to 70 years; 2. The estimated lifetime is not less than 3 months; 3. Pathologically confirmed hormone receptor (ER and PR negative) and HER2 negative advanced breast cancer; if there are multiple pathological results, the definition of triple negative breast cancer is the final subtype of the last biopsy pathological molecular subtype; 4. Metastatic breast cancer diagnosed by pathology that is not suitable for local surgery; 5.Had not received systemic chemotherapy, immunotherapy or targeted therapy before; Patients receiving adjuvant chemotherapy were enrolled at least 6 months prior to their last chemotherapy. 6. ECOG PS 0-2 points, no disease has deteriorated in the past 2 weeks; 7. There are RECIST1.1 requirements for measuring lesions, and imaging examinations are required within 4 weeks before enrollment (all local top A hospitals can perform examinations) to assess current tumor lesions; 8. At the time of randomization, the previous treatment-related toxicity should be relieved to NCI CTCAE (version 4.0) =3.0x10^9/L; (2) Neutrophil count (ANC) >=1.5x10^9/L; (3) platelet count (PLT) >=75x10^9/L; 10. The liver and kidney function tests are basically normal within 1 week before enrollment (based on the normal values of the laboratories in each research center): (1) Total bilirubin (TBIL) =60 ml/min; 11. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. A patient who is pregnant or breast-feeding; 2. Central nervous system metastasis (including brain parenchyma, pia mater and meningeal metastasis); 3. Diagnosis of any other malignant tumor within 3 years prior to randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ; 4. It may interfere with the accompanying disease or condition involved in the study, or any serious medical disorder that may affect the safety of the subject (eg, uncontrollable heart disease, high blood pressure, active or uncontrollable infection, active hepatitis B) Viral infection); 5. Patients who had previously received systemic chemotherapy; 6. Randomized patients who had undergone major surgical procedures (including open-heart biopsies) within the first 4 weeks, had major trauma (such as a fracture), had unhealed wounds, ulcers, or fractures at the time of screening, or were expected to require large hand surgery during study treatment; 7. Patients with a bleeding constitution or other risk of bleeding as assessed by a physician; 8. Patients who have a history of hypertensive dangerous phase or hypertensive encephalopathy; Or uncontrolled hypertension (systolic blood pressure >150mmHg or diastolic blood pressure >100mmHg after taking blood pressure lowering drugs); 9. Failure to follow protocol or oral medication; 10. Previous adjuvant therapy has involved the use of research drugs; 11. Participating in other clinical trials; 12. It is known to have a history of allergies to research drugs; 13. Randomized participants in clinical trials of other antitumor drugs in the first 4 weeks; 14. The researchers judged the subjects unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Satefy; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;overall survival;One year survival rate; | — |
Countries
China
Contacts
Public ContactDongyan Cai
The Affiliated Hospital of Jiangnan University (The 4th people’s hospital of Wuxi City)
Outcome results
None listed