Breast cancer
Conditions
Interventions
3. Capecitabine tablets
Dosage form: 0.15g: biconvex, rectangular, light peach-colored coated tablets, white
Experimental group (phase Ib study) - single-arm trial:The starting dose of anlotinib is 8 mg, and the dose is escalated from the low-dose group to the high-dose group. The planned escalating doses ar
Experimental group (phase II study) - randomized controlled trial:1. Toripalimab injection:
Dosage form: sterile water injection dosage form 240mg/6ml/bottle
Usage: 240mg, intravenous infusion on the first day, every 21 days for a cycle
2. Anlotinib hydrochloride capsules:
Dosage form: 12mg, 10mg, 8mg
Usage: 12mg or 10mg or 8mg once a day, continuous oral administration for 2 weeks and 1 week, every 21 days as a cycle, use
If there is a missed dose during the drug period, and it is confirmed that t
Control group (phase II study) - randomized controlled trial:1. Eribulin mesylate injection
Dosage form: colorless clear solution 2ml: 1mg/piece
Usage: 1.4mg/m^2, intravenous bolus within 2-5 minutes, administered once on day 1 and day 8, every 21 days for a cycle
2. Vinorelbine tartrate injection
Dosage form: This product is a colorless to yellowish clear liquid
Usage: 25mg/m^2, administered once on day 1 and day 8, every 21 days for a cycle
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Study participants or their legal representatives voluntarily sign an informed consent form in writing; 2. Age 18~75 years old (including upper and lower limits), male or female; 3. Cytological or histological diagnosis of HER2-negative breast cancer (HER2-negative must meet one of the following conditions: IHC0; IHC1 ; IHC2 should be further determined by in situ hybridization (ISH) to determine HER2 negative); 4. Patients with recurrent or metastatic breast cancer who have progressed after prior treatment with purple-liner chemotherapy drugs; Patients who have progressed on prior neoadjuvant and/or adjuvant taxane therapy are allowed to be included, provided that the interval between recurrence/metastasis at the end of taxane (neoadjuvant therapy) is CPS =1; 6. Clear evidence of disease progression confirmed by the investigator or documented in medical history; 7. At least one measurable target lesion according to criteria RECIST1.1; 8. ECOG functional status score of 0~1 points; 9. Archival tumor tissue specimens or fresh tissue samples from primary or metastatic lesions can be tested for PDL1; 10. Have adequate organ and bone marrow function (refer to the upper limit of normal value of each clinical trial center): a) Bone marrow function: absolute neutrophil value (ANC) >=1.5×10^9/L; platelets>=100×10^9/L; hemoglobin > = 90 g/L; b) Liver function: total bilirubin =50mL/min (according to Cockcroft and Gault formula); d) Coagulation function: international normalized ratio value (INR) =2, additional testing of 24-hour urine protein quantification, such as 24-hour urine protein =3 months.
Exclusion criteria
Exclusion criteria: 1. Presence of brainstem, meningeal metastases, spinal cord metastases or compression; Active central nervous system metastases. However, subjects with previously treated brain metastases (e.g., surgery, radiotherapy) are allowed to be enrolled if they are clinically stable for at least two weeks after treatment (counting from the start of the day of enrollment) and corticosteroids are discontinued within 14 days prior to enrollment; Subjects with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for treatment such as corticosteroids, and lesion 140 mmHg and/or diastolic blood pressure > 90 mmHg) that is not controlled by medication; 4. History of arterial thrombosis, deep vein thrombosis within 6 months prior to enrollment: such as pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, etc., but catheter-related adherent thrombosis that does not require treatment can be enrolled; 5. Significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis), unstable angina, New York Heart Association (NYHA) classification >=III. cardiac insufficiency, severe arrhythmia uncontrolled by medication; 6. History of major surgery and major trauma within 4 weeks prior to enrollment; Subjects with any signs or history of bleeding constitution, regardless of severity; Subjects with any bleeding or bleeding event within 4 weeks prior to the first dose >= CTCAE3 grade; or the presence of unhealed wounds, fractures, active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; 7. Presence of any active autoimmune disease or history of autoimmune disease with expected recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, hypophysitis, vasculitis, etc.); However, the following diseases are excluded: stable type I diabetes mellitus treated with fixed-dose insulin; Hypothyroidism requiring only hormone replacement therapy or no treatment required; Skin diseases that do not require systemic treatment (such as eczema, rash that occupies less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.); 8. Have a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, history of drug-induced pneumonia or evidence of active pneumonia requiring treatment on chest CT examination during the screening period; Patients with active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis therapy or have received anti-tuberculosis therapy within 1 year prior to screening; 9. Uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage; 10. Those who are positive for hepatitis B surface antigen and HBVDNA>=ULN, or those who are positive for hepatitis C virus antibody and human immunodeficiency virus antibody; 11. Pregnant or lactating female subjects; Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate(CBR);Objective response rate(ORR);Overall survival;Safety index;Duration of objective response;Quality of life; | — |
Countries
China
Contacts
Public ContactJing Wu, Xiaohua Zeng
Chongqing University Cancer Hospital
Outcome results
None listed