Overview
A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-12-31
2022-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
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 mesylate in patients with advanced triple-negative breast cancer. We will enroll 46 subjects (Simons two stage design). This study aims to evaluate the efficacy and safety of camrelizumab combined with apatinib and eribulin in the treatment of advanced TNBC.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityTreatments:
Apatinib
Criteria
Inclusion Criteria:1. The patients sign the written informed consent.
2. Women aged 18-70.
3. 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.
4. 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.
5. The patient can swallow pills.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
7. With a life expectancy of at least 12 weeks.
8. 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
9. 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:
1. The subjects had a central nervous system metastases with clinical symptoms.
2. Other clinical trials of drugs were used in the first four weeks before the first
dose.
3. Subjects with severe allergic reactions to other monoclonal antibodies.
4. Received other anti-tumor treatments within 28 days before the first dose.
5. A heart condition or disease that is not well controlled.
6. Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous
use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
7. The subjects had any history of autoimmune disease or any use of systemic
glucocorticoid or immunosuppressive medications.
8. Subjects had history of hypertension and poor control with antihypertensive medication
(systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
9. Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity
≥ 1.0g.
10. Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia,
coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
11. Congenital or acquired immune deficiency (such as HIV infection);
12. Receive live vaccine within 4 weeks before or during the study period;
13. Patients who are allergic to or contraindicated to the experimental drugs.