Advanced triple-negative breast cancer (TNBC)
Conditions
Interventions
Experimental Group:Camrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m2, IV, Day 1 and Day 8) administered in 21-day cycles.
Control Group:The investigator chooses one of the following four medications (every 21 days as a course).
1. Elibulin
2. Gemcitabine
3. Vinorelbine
4. Gosatuzumab.
Patients are treated until intolerable side effects or disease progression.
Sponsors
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study and sign the informed consent form; 2. Female patients with >=18 years old and =1 line of systemic therapy for metastatic or locally advanced unresectable TNBC with disease progression, and the front-line systemic therapy (including >=1 line of chemotherapy and neoadjuvant/adjuvant chemotherapy) includes at least purple-shirt or anthracycline chemotherapy; Subjects who relapse within 6 months of the end of neoadjuvant/adjuvant chemotherapy are considered to have failed 1 line of therapy; 5. Able to swallow tablets; 6. ECOG score: 0~1; 7. Expected survival>=12 weeks; 8. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during the screening period): :(1) Absolute neutrophil count>=1.5×10^9/L; (2) Platelets>=100×10^9/L; (3) hemoglobin >=9g/dL; (4) serum albumin>=3g/dL; (5) Thyroid-stimulating hormone (TSH) =60mL/min; 9. Female subjects of childbearing potential agree to practice highly effective contraception starting 7 days prior to the first dose until 24 weeks post-dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
Exclusion criteria
Exclusion criteria: 1. Subjects with untreated active brain metastases or meningeal metastases; 2. Participation in any other interventional clinical trial within 28 days prior to the first dose; 3. Severe allergic reaction to other monoclonal antibodies; 4. Other anti-tumor therapy within 28 days prior to the first dose; 5. Patients with hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 6. Patients who have received prior antibodies such as CTLA-4, Tim3, LAG3, etc., or T cell co-stimulation therapy (prior use of PD-1 or PD-L1 antibodies is allowed); 7. Previous anti-angiogenic drug therapy or eribulin chemotherapy; 8. Subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or who have had complete remission of asthma in childhood and do not require any intervention after adulthood may be included; Asthma in participants requiring medical intervention with bronchodilators could not be included); 9. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 10. Urine routine showed urine protein >=, or confirmed 24-hour urine protein volume >=1.0 g; 11. Known hereditary or . Acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 12. Subject congenital or acquired immunodeficiency (such as HIV infection); 13. Live vaccine received less than 4 weeks prior to study administration or possibly during the study period; 14. Patients who are allergic to the trial drug or whose use is contraindicated; 15. Surgery within 3 months prior to enrollment of the patient or anticipated need for major surgical procedure during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Clinical Benefit Rate;Duration of Response;Time to Response;Two-Year Overall Survival Rate;Tumor and Peripheral Blood Biomarker Analysis;QoL Analysis;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactJieqiong Liu
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Outcome results
None listed