Actively Recruiting
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer
Led by Sun Yat-sen University · Updated on 2024-02-20
302
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.
CONDITIONS
Official Title
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form
- Aged over 18 years old, regardless of gender
- Locally advanced or metastatic breast cancer confirmed by histopathology
- Received 2 or more previous lines of anti-tumor treatment and developed resistance to standard treatment
- Life expectancy of 3 months or more
- ECOG performance status between 0 and 2
- Have measurable or evaluable lesions based on RECIST 1.1 standards
- No serious heart, lung, liver, or kidney functional abnormalities
- Routine blood counts meeting minimum thresholds: WBC 2 3 �D7 10^9/L, ANC 2 1.5 �D7 10^9/L, platelets 2 100 �D7 10^9/L, hemoglobin 2 8 g/dL
- Blood biochemical tests within specified limits including liver enzymes, bilirubin, and kidney function
- Coagulation tests within normal ranges unless on warfarin
- Able to comply with research visits and study requirements
- Female patients of childbearing age must use effective contraception and have a negative pregnancy test before treatment
- No absolute contraindications to tissue-invasive procedures for organoid culture (for OGPT group)
- Sufficient tissue available for organoid culture from biopsy, surgery, or malignant effusions (for OGPT group)
You will not qualify if you...
- Currently participating in other interventional clinical studies or ended treatment in previous clinical study less than 4 weeks ago
- Received anti-tumor treatment less than 4 weeks ago or unresolved treatment-related side effects above grade 1
- Having other active cancers that require treatment
- History of organ or stem cell transplantation
- Major surgery or severe trauma within 14 days before enrollment
- Active pulmonary tuberculosis or history of active tuberculosis within the past year
- Severe acute or chronic infection requiring systemic treatment
- Heart failure (NYHA class III or IV), uncontrolled coronary artery disease or arrhythmia, recent myocardial infarction within 6 months
- Pregnant or breastfeeding women
- No planned anti-tumor treatment
- Known HIV infection or AIDS
- Untreated active hepatitis B or C, or co-infection
- Allergy or hypersensitivity to any study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yanxia Shi
Guangzhou, None Selected, China, 510060
Actively Recruiting
Research Team
Y
Yanxia Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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