Camrelizumab plus apatinib and eribulin versus physician's choice chemotherapy for advanced triple-negative breast cancer

A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer

This trial tests whether combining camrelizumab, apatinib, and eribulin works better than your doctor's chosen chemotherapy for adults with advanced triple-negative breast cancer who have had 1–4 prior systemic treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, camrelizumab, apatinib
• Locations: 7 sites (Guangzhou, Guangdong and 6 other locations)
• Trial ID: NCT06889688 on ClinicalTrials.gov

What this trial studies

This randomized Phase III trial compares a triplet regimen (camrelizumab, an anti–PD-1 antibody; apatinib, an oral VEGFR2 inhibitor; and eribulin chemotherapy) against physician's choice chemotherapy in patients with advanced or metastatic triple-negative breast cancer. Eligible patients are adult women with pathologically confirmed TNBC and at least one measurable lesion who have received between one and four prior lines of systemic therapy. The main outcomes are progression-free survival and overall survival, with secondary endpoints including response rates, duration of response, biomarker studies, quality of life, and safety. The trial is being conducted at multiple tertiary hospitals in China with standard safety monitoring and adverse event reporting.

Who should consider this trial

Good fit: Adult female patients (18–70 years) with pathologically confirmed advanced or metastatic triple-negative breast cancer, at least one measurable lesion, and who have received 1–4 prior systemic therapies (including prior taxane or anthracycline) are ideal candidates.

Not a fit: Patients who do not have triple-negative disease, who fall outside the age or prior-treatment criteria, or who have uncontrolled comorbidities or poor organ function are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could extend progression-free and overall survival and increase response rates compared with standard chemotherapy in later-line advanced TNBC.

How similar studies have performed: Earlier-phase studies combining immunotherapy with anti-angiogenic agents and chemotherapy in TNBC have shown promising activity, but this specific camrelizumab+apatinib+eribulin triplet is now being tested in a Phase III setting.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 6 other locations

• 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)

Study contacts

• Study coordinator: Jieqiong Liu, M.D., Ph.D.

Conditions Breast Cancer Stage IV; Triple -Negative Breast Cancer; Advanced Triple-Negative Breast Cancer; Immunotherapy