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

ConditionsBreast Neoplasms Neoplasm Metastasis Drug Therapy Bevacizumab

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorWang Jiayu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old，and ≤75 years old.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Expected survival period not less than 12 weeks.

At least 1 measurable lesion according to RECIST 1.1 standard.

Disqualifiers

There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).

Symptomatic or uncontrolled brain or meningeal metastases.

Patients with only bone or skin metastasis as the assessable lesion.

Previously suffered from other malignant tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: eribulin+bevacizumabExperimental treatment 2 interventions

Group B: eribulinActive comparator 1 intervention

Trial outcomes

Primary outcomes

progression-free survival (PFS)

PFS is defined as the time from randomization to the date of confirmed radiological progression or death from any cause.

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.

Secondary outcomes

overall survival (OS)

OS is defined as the time from randomization to the date of death from any cause and censored at the date of final contact for patients who were still alive.

Time frame

The long-time survival will be followed every 3 months after the end of treatment.

objective response rate (ORR)

ORR is defined as the proportion of patients with best response of complete response (CR) and partial response (PR) according to RECIST 1.1 standard.

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 efficacy will be evaluated according to RECIST 1.1 standard.

clinical benefit rate (CBR)

CBR is defined as the proportion of patients with best response of complete response (CR) , partial response (PR) and stable disease (SD) according to RECIST 1.1 standard.

Time frame

Radiological examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard.

Other outcomes

treatment-related adverse events (TRAE)

TRAE is defined as the adverse reactions that occur during the use of medication for treatment and are supposed to be related to the intervention drugs.

Time frame

Adverse events will be assessed every cycle (each cycle is 21 days) and graded according to the Common Terminology Criteria Adverse Events (CTCAE) version 5 until 1 month after the end of treatment.

quality of life (QoL)

QoL assessment is examined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30), of which 30 items were included. Items 1-28 are divided into 4 levels, with ratings ranging from 1 to 4 (the higher score indicates worse life quality). Items 29 and 30 are divided into 7 levels, with ratings ranging from 1 to 7 (the higher score indicates better life quality).

Time frame

The life quality questionnaire is arranged at baseline and every 3 months after enrollment until 6 months after the end of treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wang Jiayu

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov

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