Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial

Explore the Efficacy and Safety of Eribulin Combined With Sintilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer

This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Eribulin; Drug: Sintilimab

Detailed Description

Eribulin: According to the standard dose,1.4mg/m^2 day1、8，repeated every 3 week. After 6 cycles, the investigator decided whether to continue treatment depending on the patient's tolerance.

Sintilimab: 500mg once every three weeks. The patients were treated until disease progression or intolerable side effects.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ying Xi Shao, doctor; Phone Number: 15824113524; Email: 15824113524@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • zhejiangCH
      • Contact: Ying Xi Shao, doctor; Phone Number: 15824113524; Email: 15824113524@163.com
      • Principal Investigator: Jia Xiao Wang, doctor
      • Contact: Jia Xiao Wang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Written informed consent. 2. Women aged 18 years or older. 3. Eastern Cooperative Oncology Group(ECOG) has a physical fitness score of 0 or 1. 4. Life expectancy is more than six months. 5. Diagnosed as HER2-negative metastatic breast cancer. 6. There was at least one measurable lesion according to RECIST 1.1. 7.Patients with HR-positive HER2-negative metastatic breast cancer received first-line endocrine therapy, including endocrine therapy alone or in combination with a CDK4/6 inhibitor. 8.In the neoadjuvant or adjuvant stage, patients who had received treatment with anthracyclines or taxanes had recurrence or metastasis more than 6 months after the last administration. 9.Patients who are HR-positive can receive first-line endocrine therapy. 10.Good organ function. 11.Fertile female patients must have a negative serum pregnancy test within seven days prior to study treatment and consent to effective contraceptive use for 180 days from screening to the last dose of study treatment. 12.Female patients must agree not to breastfeed during the study period or for 180 days after the last dose of study therapy.

Exclusion Criteria:

• 1.In the metastatic stage, previous use of Eribulin or immunotherapy or other drug chemotherapy. 2.Patients enrolled in any interventional clinical trial at the same time and received the investigational therapy ≤ four weeks prior to initiation of the regimen or at least five half-lives of the investigational drug. 3.Patients who had received radiation therapy with bone marrow coverage >20% within two weeks before the start of treatment, except for minor palliative radiation therapy more than one week before the first day of the study. 4.Patients with a visceral crisis, and requiring chemotherapy. 5.Patients allergic to Eribulin or Sintilimab. 6.

Patients received blood transfusions ( platelets or red blood cells ) within 4 weeks before the initiation of treatment. 7.Patients received colony stimulating factors ( such as granulocyte colony stimulating factor [ g-CSF ], granulocyte macrophage colony stimulating factor or recombinant erythropoietin ) within 4 weeks before the start of treatment. 8.A history of platelet transfusion for chemotherapy-induced thrombocytopenia or prior cancer treatment (lasting > 4 weeks and associated with recent treatment) is known to result in ≥ grade 3 hematological toxicity. 9.The patient had any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 10.Patients have a severe, uncontrolled medical condition, a non-malignant systemic disease, or an active, uncontrolled infection. 11.Patients diagnosed, detected, or treated for another type of cancer within ≤2 years prior to beginning regimen therapy. 12.Patients with brain metastases or pial metastases uncontrolled. 13.Patients have received an allogeneic bone marrow transplant or double umbilical cord blood transplant. 14.Patients cannot swallow oral medications. 15.Patients with gastrointestinal disorders that may interfere with the absorption of investigational drugs. 16.Patients have had systemic active autoimmune disease (i.e., disease modulators, corticosteroids, or immunosuppressants) within the past two years.

17.Patients with a history of human immunodeficiency virus, active-hepatitis -B or C.

18.Pregnant or nursing women. Fertile adults without effective contraceptive methods.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eribulin Combined With Sintilimab; Eribulin: 1.4mg/m^2 day1、8，repeated every 3 week. Sintilimab: 500mg once every three weeks.	Drug: Eribulin; 1.4mg/m^2 day1、8，repeated every 3 week.; Other Names: eribulin mesylate; Drug: Sintilimab; 500mg once every three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time to death from any cause from the date of first dose of study treatment	up to 24 months
adverse event(AE)	Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0.	Throughout the experiment, assessed up to 24 months.
Progression-Free Survival (PFS)	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first.	up to 24 months
Clinical Benefit Rate (CBR)	Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeksin the ITT analysis set.	up to 24 months
Duration of Overall Response(DoR)	ime from first recording to CR or PR to disease progression or all-cause death.	up to 24 months
Time to response (TTR)	TR defined as the time from the date of the first dose of study treatment to the first objective tumor response when CR or PR is observed.	up to 24 months

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 8, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Eribulin; Metastatic Breast Cancer; Sintilimab; HER2-negative; First-line Treatment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-2024-198

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No