Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast

Status Recruiting

Clinical Trial Summary

Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.

Clinical Trial Description

58 early-stage breast cancer patients scheduled to undergo neoadjuvant therapy will be recruited. Baseline information including medical history, ultrasound, Breast-Specific Gamma Imaging (BSGI), and magnetic resonance imaging (MRI) records, will be collected both before and after two cycles of chemotherapy. Tumor tissue from these patients will be obtained via biopsies guided by ultrasound. Patient-derived organoids (PDOs) will be established and cultured from the collected tumor tissue. Subsequently, these PDOs will be subjected to treatment with drugs from standard chemotherapeutic regimens for breast cancer. The growth of the organoids will be assessed post-treatment, and dose-response curves will be generated. For evaluating the clinical outcomes of the patients, the Residual Cancer Burden (RCB) system will be used to evaluate tumor histological responses in patients. The consistency between treatment responses observed in the PDO models and the clinical outcomes of patients will be evaluated through correlation analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06155305
Study type	Observational
Source	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact	ZHIGANG CHEN
Phone	+8657189713716
Email	chenzg@zju.edu.cn
Status	Recruiting
Phase
Start date	December 6, 2023
Completion date	June 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer — ONAC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms