Actively Recruiting
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Led by Guangdong Provincial People's Hospital · Updated on 2024-11-25
252
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
CONDITIONS
Official Title
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent before any study procedures
- Men or women aged 18 years or older
- Pathologically confirmed unresectable locally advanced or metastatic HER2-negative breast cancer
- Hormone receptor status can be positive or negative
- Treated with at least one prior systemic therapy in advanced or metastatic setting
- Documented radiologic progression during or after most recent treatment
- At least one measurable tumor lesion by CT or MRI per RECIST 1.1
- ECOG performance status 0 or 1
- Recent tumor sample available or willing to undergo tissue biopsy before randomization
- No visceral crisis
- Life expectancy of at least 6 months
- Completed required baseline labs and imaging within 28 days before randomization
- Normal organ and bone marrow function within 28 days before study treatment
- Negative pregnancy test within 2 weeks before randomization for those of reproductive potential and agreement to use non-hormonal birth control during and for 6 months after treatment
- For organoid-guided treatment group: no absolute contraindication for invasive sampling procedures
- Sufficient tumor material available for organoid generation
- Successful solid tumor biopsy sample with at least 20% tumor content or malignant effusion sample confirmed to contain malignant cells
You will not qualify if you...
- Ineligible for all five study treatments due to prior treatment or contraindications
- Known harmful mutations in BRCA1 or BRCA2 genes
- Active central nervous system metastases or progressive brain tumors
- Inflammatory breast cancer
- History of severe allergic reactions to study drugs or their ingredients
- Major surgery within 3 weeks before starting study treatment
- Systemic anticancer, antibody-based, hormonal, or radiotherapy within 3 weeks before study treatment
- Participation in another therapeutic clinical study within 3 weeks before study treatment
- Multiple primary cancers within past 3 years except certain skin or breast cancers
- Unresolved toxicities from prior anticancer therapy except hair loss
- Substance abuse or significant heart, lung, or psychological conditions that increase safety risk or interfere with participation
- Known HIV infection or active hepatitis B or C infection
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Gastrointestinal problems likely to affect absorption of study medication
- Pregnant, breastfeeding, or planning pregnancy
- Any condition that the investigator believes makes participation inappropriate or would affect protocol compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
K
Kun Wang, M.D.
CONTACT
H
Hong-Fei Gao, M.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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