Actively Recruiting
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
Led by Akeso · Updated on 2026-03-16
416
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
CONDITIONS
Official Title
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2 status
- No prior systemic treatment for advanced breast cancer
- Suitable for taxane-based monotherapy
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function
You will not qualify if you...
- Locally recurrent disease eligible for surgery or radiotherapy
- History of other malignancies within the past 5 years
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Pregnant or breastfeeding women
- Participation in another clinical trial unless observational or follow-up phase
- Clinically symptomatic pleural effusion, pericardial effusion, or ascites needing repeated drainage
- History of immune deficiency, positive HIV test, or long-term use of systemic corticosteroids or immunosuppressants
- Known active tuberculosis or suspected active tuberculosis
- Known active syphilis infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
X
Xufang Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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