Actively Recruiting
Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-04-23
246
Participants Needed
7
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years at the time of consent signing
- Pathologically confirmed advanced triple-negative breast cancer with specific ER, PR, and HER2 negative status
- At least one measurable lesion according to RECIST v1.1 criteria
- Received 1 to 4 prior systemic therapy lines for metastatic or locally advanced unresectable TNBC including at least a taxane or anthracycline
- Able to swallow tablets
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate vital organ function based on blood counts and biochemical tests
- Women of childbearing potential agree to use effective contraception and have a negative pregnancy test within 7 days prior to first dose
You will not qualify if you...
- Untreated active brain or leptomeningeal metastases
- Participation in another interventional clinical trial within 28 days before first dose
- History of severe allergic reactions to monoclonal antibodies
- Received other antitumor therapies within 28 days before first dose
- Uncontrolled hypertension despite treatment (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Previous treatment with CTLA-4, Tim-3, or LAG-3 antibodies or T-cell co-stimulatory therapies
- Prior use of anti-angiogenic agents or eribulin chemotherapy
- Active or past autoimmune disease except vitiligo or fully resolved childhood asthma
- Uncontrolled cardiac symptoms or diseases including NYHA Class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Proteinuria ≥++ on urinalysis or ≥1.0 g/24h confirmed
- Known hereditary or acquired bleeding or clotting disorders
- Congenital or acquired immunodeficiency such as HIV
- Receipt of live vaccine within 4 weeks before or during the study
- Allergy or contraindication to study drugs
- Major surgery within 3 months before enrollment or planned during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Actively Recruiting
2
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
3
Wuhan Union Hospital of China
Wuhan, Hubei, China
Not Yet Recruiting
4
Yichang Central People's Hospital
Yichang, Hubei, China
Actively Recruiting
5
Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
6
The Central Hospital Of Yong Zhou
Yongzhou, Hunan, China
Actively Recruiting
7
Changhai Hospital of Shanghai
Shanghai, China
Actively Recruiting
Research Team
J
Jieqiong Liu, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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