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

Primary Purpose

TNBC - Triple-Negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Eribulin
anti-PD-1 antibody
Sponsored by
Beijing 302 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer focused on measuring TNBC, Eribulin, anti-PD-1 antibody

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Fifth Medical Center of PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eribulin in combination with anti-PD-1 antibody

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with Adverse Events
Adverse Events are monitored throughout the trial and for 30 days after discontinuation of treatment (90 days for serious adverse events) and graded according to the Common Terminology Criteria for Adverse Events, version 4.0, of the National Cancer Institute.
the correlation between the expression of PD-L1 of circulating tumor cells and prognosis
To detect the differences of the expression of PD-L1 in patients with different curative effects and prognosis,including the number of circulating tumor cells,and PD-L1 expression or others.

Full Information

First Posted
April 13, 2022
Last Updated
May 29, 2022
Sponsor
Beijing 302 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05402722
Brief Title
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
Official Title
A Phase II Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TNBC - Triple-Negative Breast Cancer
Keywords
TNBC, Eribulin, anti-PD-1 antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eribulin in combination with anti-PD-1 antibody
Arm Type
Experimental
Arm Description
Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) .
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Halaven
Intervention Description
Eribulin Mesylate,1.4mg/m2,Intravenous infusion,d1,d8,3-week cycle
Intervention Type
Drug
Intervention Name(s)
anti-PD-1 antibody
Intervention Description
Sintilimab Injection,Intravenous infusion,200mg,3-week cycle
Primary Outcome Measure Information:
Title
Progression Free Survival,PFS
Description
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
Time Frame
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 Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
Adverse Events are monitored throughout the trial and for 30 days after discontinuation of treatment (90 days for serious adverse events) and graded according to the Common Terminology Criteria for Adverse Events, version 4.0, of the National Cancer Institute.
Time Frame
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
Title
the correlation between the expression of PD-L1 of circulating tumor cells and prognosis
Description
To detect the differences of the expression of PD-L1 in patients with different curative effects and prognosis,including the number of circulating tumor cells,and PD-L1 expression or others.
Time Frame
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaobo wang, doctor
Phone
+86-010-66947250
Email
724292466@qq.com
Facility Information:
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wang
Phone
+86-010-66947172
Email
wangtaotg@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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