A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC

NCT04303741 | Unknown Phase 2 DMC

• 1 other identifier: Immuno2020-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The propotion of subjects with CR or PR.

  from the first drug administration up to the first occurrence of progression or death (up to 24 months)

Secondary Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events

  from the first drug administration to within 90 days for the last dose

• Disease Control Rate (DCR)

  from the first drug administration up to the first occurrence of progression or death(up to 24 months)

• DOR

  from the first drug administration up to the first occurrence of progression or death(up to 24 months)

• PFS

  from the first drug administration up to the first occurrence of progression or death (up to 24 months)

• One year-OS rate

  12 months after the first drug administration

Study Arms (1)

Camrelizumab +Apatinib+Eribulin

EXPERIMENTAL

Camrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv Q3W combination with Apatinib 250mg, po, daily (d1-d21)and Eribulin1.4mg/m2 iv d1, d8 Q3W

Drug: Camrelizumab; Drug: Apatinib; Drug: Eribulin

Interventions

Camrelizumab DRUG

Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

Camrelizumab +Apatinib+Eribulin

Apatinib DRUG

Apatinib 250mg will be administered daily until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

Camrelizumab +Apatinib+Eribulin

Eribulin DRUG

Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

Also known as: Eribulin Mesylate

Camrelizumab +Apatinib+Eribulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (3)

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Changhai Hospital, Navy Medical University (Second Military Medical University)

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Liu J, Wang Y, Tian Z, Lin Y, Li H, Zhu Z, Liu Q, Su S, Zeng Y, Jia W, Yang Y, Xu S, Yao H, Jiang W, Song E. Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022 May 31;13(1):3011. doi: 10.1038/s41467-022-30569-0.

  PMID: 35641481 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

camrelizumab; apatinib; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jieqiong Liu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: March 11, 2020
• Study Start: March 25, 2020
• Primary Completion: November 30, 2022
• Study Completion: August 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)