Clinical Study on Drug Sensitivity Verification or Prediction of Therapy for Breast Cancer by Patient-Derived Organoid Model

Organoid Clinical Trial

Official title: Clinical Study on Drug Sensitivity Verification or Prediction of Therapy for Breast Cancer by Patient-Derived Organoid Model

Status Recruiting

Clinical Trial Summary

This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 2 years. The purpose of this study is to evaluate the consistency and accuracy of Patient-Derived Organoid Model of breast cancer to predict the clinical efficacy of the drug, as well as the possibility of guiding the neoadjuvant chemotherapy.

Clinical Trial Description

After obtaining informed consent, patients who met the eligibility criteria underwent biopsy of the primary lesion or metastatic lesion (such as lymph node).Under the premise of ensuring normal detection requirements, a certain volume of fresh tumor tissues will be retained and used for the cultivation of Patient-Derived Organoid Model.If the organoid cultivation is not successful, the corresponding follow-up observation will be stopped.If the organoid cultivation is successful, drug sensitivity verification or prediction by Patient-Derived Organoid Model will be completed (final report will be available in about one month). During this period, the patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen) and Herceptin was treated in HER2 amplification patients. After 3 cycles, the efficacy was assessed according to the RECIST solid tumor evaluation standard (version 1.1), and the evaluation methods mainly included physical examination, ultrasound, CT and MRI.If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks) and Herceptin was treated in HER2 amplification patients.If the evaluation of the curative effect is SD or PD, according to the result of drug sensitivity of the class organ, combined with the clinical practice, the doctor chooses the most sensitive treatment plan, and continues the 2 cycle treatment (6 weeks).After the completion of the evaluation, combined with the clinical situation, the next step is decided.For those who meet the conditions of the operation, the modified radical mastectomy or breast conserving surgery was performed after the neoadjuvant chemotherapy. The pCR status of the primary breast cancer and the axillary lymph nodes were evaluated after the operation. The adjuvant radiotherapy and endocrine therapy were given after the operation, and the long-term survival was observed.

Drug sensitivity tests include single drug and drug combination. The organs that are successfully cultured will be kept in liquid nitrogen for a specific time. ;

Related Conditions & MeSH terms

• Organoid

• NCT number: NCT03544047
• Study type: Interventional
• Source: Peking Union Medical College
• Contact: Fei Ma, Professor
• Phone: 8610-87787652
• Email: drmafei@126.com
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: July 1, 2020