Status:
UNKNOWN
A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This is a phase II, open-labeled, multi-centered,single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) and eribulin mesy...
Detailed Description
This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib and eribulin in female pati...
Eligibility Criteria
Inclusion
- The patients sign the written informed consent.
- Women aged 18-70.
- 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.
- Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
- The patient can swallow pills.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- With a life expectancy of at least 12 weeks.
- 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.
- Other clinical trials of drugs were used in the first four weeks before the first dose.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- Received other anti-tumor treatments within 28 days before the first dose.
- A heart condition or disease that is not well controlled.
- Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
- The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
- Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
- 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.
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04303741
Start Date
March 25 2020
End Date
August 31 2023
Last Update
April 12 2023
Active Locations (3)
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1
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
3
Changhai Hospital, Navy Medical University (Second Military Medical University)
Shanghai, Shanghai Municipality, China, 200433