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

NCT06268652 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yanxia Shi · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-02-15
Completion
2028-01-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268652 on ClinicalTrials.gov