Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
About this trial
This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer focused on measuring TNBC, Eribulin, anti-PD-1 antibody
Eligibility Criteria
Inclusion Criteria:
- The patients sign the written informed consent.
- Women aged 18-75.
- The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)]. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
- PD-1/PD-L1positive or TMB≥5.
- Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
The results of patient's blood tests are as follows:
• Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
Exclusion Criteria:
- The subjects had a central nervous system metastases with clinical symptoms.
- Subjects with treatment history of PD-1 / PD-L1 inhibitors;
- Peripheral neuropathy ≥ grade 2; Cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; Autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease.
- Pregnant or lactating women.
- Other clinical trials of drugs were used in the first four weeks before the first dose.
- The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
- Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
- Congenital or acquired immune deficiency (such as HIV infection);
- Receive live vaccine within 4 weeks before or during the study period;
- Patients who are allergic to or contraindicated to the experimental drugs.
- Other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease.
- Subjects with any other diseases that are unfit for the treatment.
Sites / Locations
- The Fifth Medical Center of PLA General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Eribulin in combination with anti-PD-1 antibody
Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) .