Actively Recruiting
Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer
Led by Fujian Cancer Hospital · Updated on 2024-09-19
29
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.
CONDITIONS
Official Title
Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Volunteered to participate and signed informed consent
- Histologically or pathologically confirmed advanced triple negative breast cancer with specific tumor staging and negative HER2 and hormone receptor status
- Previous systemic therapy including anthracyclines for recurrence or metastasis
- Presence of measurable lesions according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- No prior treatment with apatinib or albumin-bound paclitaxel except in neoadjuvant or adjuvant setting
- Adequate marrow, liver, and renal function as defined by specific laboratory values
- Female subjects of child-bearing potential agree to use contraception from one week before first dose until eight weeks after discontinuation of study drug
You will not qualify if you...
- Pregnant or lactating women
- Previous or coexisting malignancies except certain skin, bladder, cervical, or other cancers in situ with complete remission for at least 5 years
- Patients with consciousness disorders, mental illness, or central nervous system metastasis
- Participation in other clinical trials within the past three months
- Prior treatment with apatinib, vaso-targeting drugs, or other small-molecule tyrosine kinase inhibitors
- Received any targeted treatment before enrollment including surgery, chemotherapy, radiation, or targeted therapy
- Recent (within 3 months) esophageal varices bleeding, intestinal obstruction, or gastrointestinal perforation
- Clinical symptoms of cancerous ascites or pleural effusion
- Active infection or unexplained fever above 38.5°C within 7 days before enrollment
- Severe failure of major organs including liver, kidney, heart, lung, or brain
- Uncontrolled hypertension
- History or presence of specific lung diseases or active pneumonia
- Abnormal coagulation prone to bleeding or receiving certain anticoagulant therapies
- Uncontrolled cardiac symptoms or diseases
- Positive urine protein at specified levels
- Inability to swallow pills or malabsorption conditions
- Recent thrombotic events within 6 months
- History of bleeding or coagulation disorders with recent significant bleeding
- Other serious diseases or conditions that may affect safety or data collection per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
Research Team
W
weiwei Huang
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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