Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06268652
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2024-01-15

Completion Date

2028-01-15

Last Updated

2024-02-20

Healthy Volunteers

No

Interventions

OTHER

Organoid-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.

DRUG

Gemcitabine

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

DRUG

Capecitabine

1000mg/m² , PO, bid, days1-14, q3w

DRUG

Vinorelbine

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

DRUG

Eribulin

1.4mg/m², IV, days 1 and 8, q3w

Locations (1)

Yanxia Shi

Guangzhou, None Selected, China