Status:
UNKNOWN
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
Lead Sponsor:
Beijing 302 Hospital
Conditions:
TNBC - Triple-Negative Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05402722
Start Date
January 1 2022
End Date
June 30 2023
Last Update
June 2 2022
Active Locations (1)
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1
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100071