Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Subjects randomly assigned to OGPT need to provide sufficient tissue for organoid culture. After successful organoid culture, drug screening will be performed, and they will be treated with drugs predicted to be sensitive by PDO drug susceptibility screening.

Subjects in the TPC arm will receive treatment with one of the following regimens selected by the physician following NCCN guidelines: capecitabine, gemcitabine, vinorelbine, and eribulin. If it is HER2-positive, anti-HER2 therapy can be combined with it, except for ADC drugs.

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.

Organoid-guided personalized treatment

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

Eribulin

Yanxia Shi

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.

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. Molecular subtype, presence of visceral metastases, and number of prior chemotherapy treatments for advanced or metastatic disease will stratify randomization. subjects in the OGPT arm will receive the treatment predicted to be the most effective by PDO drug sensitivity screening, and subjects in the TPC arm will receive treatment of physician's choice. The primary population to be included in the study will be patients with refractory breast cancer who have received multiple lines of prior therapy and who have at least one measurable target lesion according to RECIST 1.1 criteria.

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

Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.

The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.

Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.

Disease Control Rate (DCR) was defined as the percentage of patients who have achieved complete response, partial response and stable disease

Incidence of Treatment-related Adverse Events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Spots Global Cancer Trial Database for patient derived organoid