Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer

NCT05402722 | Unknown Phase 2 DMC

• 1 other identifier: breast-202204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

TNBC; Eribulin; anti-PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival，PFS

  The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

Secondary Outcomes (2)

• Number of participants with Adverse Events

  From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

• the correlation between the expression of PD-L1 of circulating tumor cells and prognosis

  From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

Study Arms (1)

Eribulin in combination with anti-PD-1 antibody

EXPERIMENTAL

Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) .

Drug: Eribulin; Drug: anti-PD-1 antibody

Interventions

Eribulin DRUG

Eribulin Mesylate，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle

Also known as: Halaven

Eribulin in combination with anti-PD-1 antibody

anti-PD-1 antibody DRUG

Sintilimab Injection，Intravenous infusion，200mg，3-week cycle

Eribulin in combination with anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients sign the written informed consent.
• Women aged 18-75.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin; spartalizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

xiaobo wang, doctor

CONTACT

+86-010-66947250; 724292466@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: June 2, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)