Actively Recruiting
Clinical Exploratory Study on Predicting Drug Sensitivity for Breast Cancer Treatment Using Simulated Organoid Models.
Led by Xiangya Hospital of Central South University · Updated on 2025-03-03
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this trial, we plan to construct a patient-derived organoid (PDO) model using fresh tumor tissue samples. Taking the relevant data of drug efficacy of breast cancer organoids as an example, it is shown that organoids may provide predictive information for drug sensitivity and may improve the therapeutic effect of advanced tumors. In this way, we aim to verify the effectiveness, feasibility and consistency of the PDO model in predicting treatment, and establish an evaluation system for treatment plans to help precision treatment of breast cancer.
CONDITIONS
Official Title
Clinical Exploratory Study on Predicting Drug Sensitivity for Breast Cancer Treatment Using Simulated Organoid Models.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Female gender
- Clinically or pathologically confirmed breast cancer
- ECOG performance status score of 0 to 1
- At least one measurable lesion according to RECIST 1.1 criteria
- Expected survival time of at least 12 weeks
- Currently receiving or planning to receive neoadjuvant therapy or anti-tumor drug treatment
- Recovery from prior treatment toxicities to grade 1 or less, except stable alopecia, vitiligo, or hypothyroidism
- Use of effective contraceptive measures during the study and for 6 months after treatment (if of child-bearing potential)
- Willingness and ability to comply with study follow-up, treatment, and testing requirements
You will not qualify if you...
- Presence of central nervous system metastasis or carcinomatous meningitis
- Bilateral breast cancer
- History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
- History of invasive or metastatic breast cancer
- Arterial or venous thrombosis events within 3 months before enrollment
- Positive HIV test or history of AIDS; active syphilis infection
- Serious diseases affecting follow-up or short-term survival
- Inability to swallow, chronic diarrhea, or intestinal obstruction affecting drug absorption
- Known allergy to study treatment drugs
- Ongoing grade 1 or higher adverse reactions from prior treatments (except alopecia or as deemed acceptable)
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other malignancies within the past 5 years except certain cured skin or cervical cancers
- Significant proteinuria or autoimmune diseases requiring treatment (exceptions apply)
- Poorly controlled hypertension or serious cardiac conditions
- Any other condition that may endanger safety or compliance as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiangya Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
J
jun Huang, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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