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

NCT ID: NCT05402722

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eribulin in combination with anti-PD-1 antibody

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

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

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

anti-PD-1 antibody

Intervention Type: DRUG

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

Interventions

Eribulin

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

Intervention Type: DRUG

anti-PD-1 antibody

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

Intervention Type: DRUG

Other Intervention Names

Halaven

Eligibility Criteria

Inclusion Criteria

1. The patients sign the written informed consent.

2. Women aged 18-75.

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. PD-1/PD-L1positive or TMB≥5.

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.

6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

7. 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

8. 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. Subjects with treatment history of PD-1 / PD-L1 inhibitors;

3. 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.

4. Pregnant or lactating women.

5. Other clinical trials of drugs were used in the first four weeks before the first dose.

6. The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.

7. Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).

8. Congenital or acquired immune deficiency (such as HIV infection);

9. Receive live vaccine within 4 weeks before or during the study period;

10. Patients who are allergic to or contraindicated to the experimental drugs.

11. Other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease.

12. Subjects with any other diseases that are unfit for the treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaobo wang, doctor

Role: CONTACT

724292466@qq.com

+86-010-66947250

Facility Contacts

Tao Wang

Role: primary

wangtaotg@163.com

+86-010-66947172

Other Identifiers

breast-202204

Identifier Type: -

Identifier Source: org_study_id