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Clinical Trials in China / NCT06889688
Recruiting Phase 3

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

NCT06889688 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 3
Started
2025-02-21
Last updated
2026-04-23

Condition(s) studied

Breast Cancer Stage IVTriple -Negative Breast Cancer

Investigational drug(s) / intervention(s)

Camrelizumab+Apatinib+EribulinPhysician's choice chemotherapy

Camrelizumab+Apatinib+Eribulin: 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: Physician's Choice Chemotherapy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF). 2. Female subjects aged ≥18 and ≤70 years on the date of signing the ICF. 3. 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. 4. 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. 5. Capable of swallowing tablets. 6. ECOG performance status of 0-1. 7. Expected survival ≥12 weeks. 8. 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. 9. 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. Exclusion Criteria: 1. Subjects with untreated active brain metastases or leptomeningeal metastases. 2. Participation in any other interventional clinical trial within 28 days prior to the first dose. 3. History of severe allergic reactions to other monoclonal antibodies. 4. Receipt of other antitumor therapies within 28 days prior to the first dose. 5. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg). 6. 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). 7. Prior treatment with anti-angiogenic agents or eribulin chemotherapy. 8. 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. 9. 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. 10. Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g. 11. Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism). 12. Congenital or acquired immunodeficiency (e.g., HIV infection). 13. Receipt of a live vaccine within 4 weeks prior to or during the study period. 14. Allergy or contraindication to the investigational drugs. 15. Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital Guangzhou Guangdong Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Recruiting
Wuhan Union Hospital of China Wuhan Hubei Not Yet Recruiting
Yichang Central People's Hospital Yichang Hubei Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
The Central Hospital Of Yong Zhou Yongzhou Hunan Recruiting
Changhai Hospital of Shanghai Shanghai China Recruiting

More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06889688 on ClinicalTrials.gov ↗ ← All trials in China