Triple negative breast cancer
Conditions
Interventions
experimental group:Anlotinib+docetaxel+lobaplatin
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 18-70 years; 2. Patients with primary stage II / III (N1-N3) triple negative breast cancer confirmed by histopathology: (1) Triple negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor (HER-2) are negative. Ish analysis showed that ER and PR values less than 1% were negative, HER-2 result (- / +) was negative, if it was (+), fish test was needed, if there was amplification, it was positive, if there was no amplification, it was negative. If HER-2 result was (- / +), fish test could be selected, but the result must be negative; (2) If there are multiple pathological results, the final subtype is the pathological molecular subtype of the last biopsy; 3. According to RECIST 1.1, the patients with at least one measurable objective lesion had tumor diameter > 2cm; 4. Subjects with ECoG score of 0-1; 5. Subjects with LVEF >= 55%; 6. Bone marrow function: neutrophils >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, hemoglobin >= 90 g / L; 7. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and alt <= 2.5 times the upper limit of normal value; Total bilirubin <= 1.5 times the upper limit of normal value, or <= 2.5 times the upper limit of normal value in patients with Gilbert's syndrome; 8. The subjects who have good compliance with the planned treatment can understand the research process of this study and sign the written informed consent. 9. Volunteers.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: 1. Patients with inflammatory breast cancer; 2. Patients who have received cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy for any reason in the past; 3. Patients with heart disease above grade II (including grade II) according to NYHA score; 4. Patients who are allergic to the active ingredients or excipients of the study drug anlotinib; 5. Patients with multiple factors (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) affecting oral drugs; 6. Patients with any severe and / or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure >= 150mmhg, diastolic blood pressure >= 100mmhg); (2) Grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 450ms (male), QTc >= 470ms (female)) and grade 2 or above congestive heart failure (NYHA classification); (3) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment; (4) Renal failure requires hemodialysis or peritoneal dialysis; (5) History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation history; (6) Poor control of diabetes mellitus (FBG > 10mmol / L); (7) Urine routine examination showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0g; (8) Patients with epilepsy and need treatment; 7. Patients with severe systemic infection or other serious diseases; 8. The patients whose imaging showed that the tumor had invaded the important blood vessels or the tumor was likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage; 9. Patients with arteriovenous thrombosis within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 10. Patients with a history of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months; 11. Subjects with any signs or history of bleeding, regardless of severity; Subjects with any bleeding or bleeding event >= CTC AE3 within 4 weeks before the first administration; Or there are some diseases of digestive tract such as unhealed wound, fracture, active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation determined by researchers; 12. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 13. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients; 14. Patients with other malignant tumors in the past 5 years, except for cervical carcinoma in situ and non melanoma skin cancer; 15. Patients of childbearing age who refused to take appropriate contraceptive measures during pregnancy or lactation and during this trial; 16. Subjects who participated in other experimental studies within 30 days before the administration of the first dose of study drug; 17. Patients who were not suitable for the study were judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR (pathologic Complete Response); | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS (Disease-Free Survival);OS (Overall Survival);Safety; | — |
Countries
China
Contacts
Public ContactXiaowei Qi
The First Affiliated Hospital of Army Medical University
Outcome results
None listed