Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer

Sponsor
Wang Jiayu
Study ID
NCT06539559
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Eribulin — DRUG
    Based on the results of STUDY301 and STUDY304, eribulin showed outstanding therapeutic effect and tolerable adverse events in patients with metastatic breast cancer
  • Bevacizumab — DRUG
    Study E2100, AVADO and RIBBON-1 found that in the first-line chemotherapy for advanced breast cancer, the addition of bevacizumab can significantly improve the efficacy of traditional chemotherapy drugs. Study RIBBON-2 and TANIA have confirmed the effectiveness of bevacizumab in the second and third line treatment of advanced HER2 negative breast cancer. Compared with chemotherapy alone, the addition of bevacizumab can prolong the PFS by 0.6 to 2.1 months.

Study Details

This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The participants will receive either eribulin combined with bevacizumab or eribulin monotherapy. Every treatment cycle will last for 21 days, with weekly monitoring of blood routine, blood biochemistry and other indicators. Imaging examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard. The life quality questionnaire is arranged at baseline and every 3 months after enrollment, and the long-time survival will be followed every 3 months after treatment. The primary endpoint is progression-free survival (PFS), the secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). The investigators will also focus on the treatment-related adverse events (TRAE) and quality of life (QoL) assessment. At the same time, this study also aims to explore the resistant mechanisms of anti-angiogenic drugs. The investigators plan to collect peripheral venous blood samples at 3 time points: baseline, during treatment, and end of treatment. All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets. And based on the optimal therapeutic efficacy, all the participants will be divided into response group and non-response group. GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks, identify key action nodes and explain the mechanism of anti-angiogenic drug resistance.

Key Dates

First listed
Aug 6, 2024
Start date
Aug 1, 2024
Status verified
Aug 2024
Primary completion
Feb 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: eribulin+bevacizumab
    eribulin 1.4 mg/m2 iv d1,8 + bevacizumab 7.5mg/kg ivgtt d1/q21d
  • Active Comparator: eribulin
    eribulin 1.4 mg/m2 iv d1,8/q21d

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: Radiological examinations will be conducted every two cycles: at the end of Cycle 2, 4, 6, 8......(each cycle is 21 days). The PFS will last until disease progression. ]

Central Contacts

Related Studies