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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sun Yat-sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting
• Yichang Central People's Hospital
  Yichang, Hubei, China Recruiting
• The Central Hospital Of Yong Zhou
  Yongzhou, Hunan, China Recruiting
• Changhai Hospital of Shanghai
  Shanghai, China Recruiting
• Wuhan Union Hospital of China
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Jieqiong Liu, M.D., Ph.D.
• Email: liujieqiong01@163.com
• Phone: +86-020-34071156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.