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

NCT06889688 | Recruiting Phase 3

• 1 other identifier: CAPER-III
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Breast Cancer Stage IV; Triple -Negative Breast Cancer

Keywords

Advanced Triple-Negative Breast Cancer; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival

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

  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.

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

Secondary Outcomes (7)

• Objective Response Rate

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

• Disease control rate

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

• Clinical Benefit Rate

  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 PD or death from any cause, whichever came first, assessed up to 120 months.

• Time to Response

  Time from randomization to the first occurrence of CR or PR, whichever came first, assessed up to 6 months

Other Outcomes (2)

• Tumor and Peripheral Blood Biomarker Analysis

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

• QoL

  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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Drug: Camrelizumab+Apatinib+Eribulin

Control Group

ACTIVE COMPARATOR

Physician's Choice Chemotherapy

Drug: Physician's choice chemotherapy

Interventions

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.

Experimental Group

Physician's choice chemotherapy DRUG

Physician's Choice Chemotherapy

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Capable of swallowing tablets.
• ECOG performance status of 0-1.
• Expected survival ≥12 weeks.
• Adequate function of vital organs, meeting the following criteria (without the use of blood products or growth factors during the screening period): Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Platelet count ≥100×10⁹/L. Hemoglobin ≥9 g/dL. Serum albumin ≥3 g/dL. Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be assessed; subjects with normal T3 and T4 levels are eligible). Total bilirubin ≤1.0×ULN (for subjects with Gilbert's syndrome or liver metastases, total bilirubin ≤1.5×ULN). ALT and AST ≤1.5×ULN (for subjects with liver metastases, ≤3×ULN). Alkaline phosphatase (ALP) ≤2.5×ULN. Renal function within 7 days prior to the first dose: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min.
• Women of childbearing potential agree to use highly effective contraception starting at least 7 days prior to the first dose and continuing for 24 weeks after the last dose. A negative serum pregnancy test is required within 7 days prior to the first dose.

You may not qualify if:

• 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.
• Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
• Prior treatment with CTLA-4, Tim-3, or LAG-3 antibodies, or T-cell co-stimulatory therapies (previous use of PD-1 or PD-L1 antibodies is allowed).
• Prior treatment with anti-angiogenic agents or eribulin chemotherapy.
• Presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Subjects with vitiligo, or childhood asthma that has fully resolved without intervention in adulthood, may be included. Subjects with asthma requiring medical intervention with bronchodilators are excluded.
• Uncontrolled cardiac clinical symptoms or diseases, including: Heart failure classified as NYHA Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g.
• Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).
• Congenital or acquired immunodeficiency (e.g., HIV infection).
• Receipt of a live vaccine within 4 weeks prior to or during the study period.
• Allergy or contraindication to the investigational drugs.
• Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (7)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Wuhan Union Hospital of China

Wuhan, Hubei, China

NOT YET RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The Central Hospital Of Yong Zhou

Yongzhou, Hunan, China

RECRUITING

Changhai Hospital of Shanghai

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jieqiong Liu, M.D., Ph.D.

CONTACT

+86-020-34071156; liujieqiong01@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)