Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

ConditionsBreast Cancer Stage IV Triple -Negative Breast Cancer

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18-70

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF).

Female subjects aged ≥18 and ≤70 years on the date of signing the ICF.

Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC-/+, or IHC++ but FISH/CISH-), with at least one measurable lesion per RECIST v1.1 criteria.

Patients who have received at least 1 and up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including at least 1 line of chemotherapy and neoadjuvant/adjuvant chemotherapy) must include at least a taxane or anthracycline. Subjects who relapse within 6 months after completion of neoadjuvant/adjuvant chemotherapy are considered as having failed first-line therapy.

Disqualifiers

Subjects with untreated active brain metastases or leptomeningeal metastases.

Participation in any other interventional clinical trial within 28 days prior to the first dose.

History of severe allergic reactions to other monoclonal antibodies.

Receipt of other antitumor therapies within 28 days prior to the first dose.

Trial design

Design model

Parallel

Treatments tested in this trial

Camrelizumab+Apatinib+Eribulin
Drug
Camrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m², IV, Day 1 and Day 8) administered in 21-day cycles.
Physician's choice chemotherapy
Drug
Physician's Choice Chemotherapy

Treatment groups

246 Participants

are divided into 2 treatment groups

Group A: Experimental GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Progression-Free Survival

Disease evaluation will be performed according to RECIST v1.1 criteria.

Time frame

Time from enrollment to the occurrence of predefined events, including disease progression or death, whichever came first, assessed up to 60 months.

Overall Survival

Death from any cause.

Time frame

From date of randomization until the date of death from any cause, assessed up to 120 months.

Secondary outcomes

Objective Response Rate

The percentage of patients in different groups whose tumor size reduction, meets the criteria for complete response (CR) or partial response (PR).

Time frame

From date of randomization until the date of first documented CR or PR, whichever came first, assessed up to 12 months.

Disease control rate

Proportion of patients achieving CR, PR, or stable disease (SD).

Time frame

From date of randomization until the date of first documented CR, PR or SD, assessed up to 12 months.

Clinical Benefit Rate

Proportion of patients achieving CR, PR, or SD.

Time frame

From date of randomization until the date of first documented CR, PR or SD for more than 6month, assessed up to 18 months.

Duration of Response

Time from the first assessment showing CR or PR to the first occurrence of progressive disease (PD) or death from any cause.

Time frame

Time from the first assessment showing CR or PR to the first occurrence of PD or death from any cause, whichever came first, assessed up to 120 months.

Other outcomes

Tumor and Peripheral Blood Biomarker Analysis

This analysis aims to identify biomarkers that predict treatment response, resistance, and prognosis in advanced triple-negative breast cancer (TNBC). Tumor Biomarker Analysis: Genetic and Molecular Profiling: Whole-exome sequencing (WES), RNA sequencing, and proteomics to identify mutations, gene expression patterns, and protein markers related to treatment response. Immune Microenvironment Assessment: Immunohistochemistry (IHC) and multiplex immunofluorescence to evaluate tumor-infiltrating lymphocytes (TILs), PD-L1 expression, and other immune-related markers. Peripheral Blood Biomarker Analysis: Measurement of inflammatory and immunomodulatory cytokines to assess systemic immune response.

Time frame

Before treatment and after 2 cycles (each cycle is 21 days) of treatment, or disease progression.

QoL

Quality of life assessment will be conducted using the EORTC QLQ-BR23 questionnaire. Raw scores will be linearly transformed to a standardized scale ranging from 0 to 100 points.

Time frame

At baseline upon enrollment and every 2cycles (each cycle is 21 days) of treatment, from date of randomization until the patient exits the study due to disease progression, adverse events, whichever came first, assessed up to 60 months.

Sponsors and contacts

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

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