Actively Recruiting
Arsenous Acid for Refractory Triple-Negative Breast Cancer
Led by Sun Yat-sen University · Updated on 2025-06-06
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess the progression-free survival (PFS) and safety of arsenous acid in combination with palliative chemotherapy for refractory triple-negative breast cancer following multiple lines of treatment.
CONDITIONS
Official Title
Arsenous Acid for Refractory Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands and voluntarily signs the informed consent form
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Life expectancy greater than 3 months
- Histologically or cytologically confirmed metastatic invasive breast cancer, negative for hormone receptor and HER2
- Refractory to at least two prior standard treatments for metastatic disease
- Eligible for one of the chemotherapy options: Eribulin, Gemcitabine, Utidelone, or Vinorelbine
- Measurable disease by CT or MRI per RECIST 1.1 criteria with lesions meeting size requirements
- Adequate bone marrow reserves and normal organ function as defined by specific blood count and liver function criteria
- Premenopausal women using medically acceptable contraception during the study
- Demonstrates good compliance
You will not qualify if you...
- Uncontrolled hypertension or persistent active infections
- Persistent toxicities from prior treatments not improved to Grade 2 or baseline levels
- Tumor-related spinal cord compression or active brain metastases
- Significant third-space fluid retention unsuitable for study
- Uncontrolled infections requiring intravenous treatment
- Known HIV positive, hepatitis B positive, or hepatitis C positive status
- Uncontrolled or significant cardiac disease within the last six months
- Suspected interstitial lung disease or non-infectious pneumonia requiring corticosteroid treatment
- Active autoimmune diseases or inflammatory conditions
- Concurrent treatment with other antitumor therapies
- Unlikely to comply with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhong-yu Yuan, M.D.
CONTACT
Z
Zhongyu Yuan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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