RecruitingPhase 3NCT06268652

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Patients With Relapsed and Refractory Breast Cancer:a Multicenter, Randomized, Controlled Phase III Trial


Sponsor

Sun Yat-sen University

Enrollment

302 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a lab-grown mini-tumor (called a patient-derived organoid) created from the patient's own cancer cells to predict which drug will work best — can lead to better treatment outcomes in patients with advanced breast cancer that has stopped responding to standard therapies. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic breast cancer confirmed by biopsy - You have already been through at least 2 prior treatment regimens and your cancer has continued to grow - Your life expectancy is at least 3 months - Your general health and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have not had prior treatment - You have serious organ dysfunction (heart, lung, liver, or kidney) - You are pregnant - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROrganoid-guided personalized treatment

After the organoid culture is successful, the personalized drug library customized by our team will be used for screening. Sensitive drugs are selected based on the results of drug screening, and the most appropriate personalized treatment plan is selected based on NCCN guideline recommendations, drug safety, and conventional drugs used in the treatment of breast cancer. The personalized drug library customized by our team contains 55 drugs approved by the FDA. For specific usage, dosage and time intervals, please refer to the instructions of the corresponding drug.

DRUGGemcitabine

1000mg/m2,IV, days 1, 8, q3w

DRUGCapecitabine

1000mg/m² , PO, bid, days1-14, q3w

DRUGVinorelbine

25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w

DRUGEribulin

1.4mg/m², IV, days 1 and 8, q3w


Locations(1)

Yanxia Shi

Guangzhou, None Selected, China

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NCT06268652


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