Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Breast Cancer Clinical Trial

— ONAC  

Official title:

Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155305
• Other study ID #: ?23-0840
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: ZHIGANG CHEN
• Phone: +8657189713716
• Email: chenzg[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent form and willingness to participate in the clinical study.

2. Female patients aged between 18 and 70 years old.

3. Confirmed early-stage breast cancer eligible for surgery (AJCC stages I to IIIA), with a tumor diameter of = 2cm detected by MRI and without distant metastasis (M0).

The largest lesion among multiple lesions has a diameter of = 2cm.

4. ECOG performance status score of 0-1.

5. No significant abnormalities in liver and kidney function (BIL <1.5-fold upper limit of normal (ULN);ALT<2.5×ULN; AST<2.5×ULN;Crea=1×ULN).

Exclusion Criteria:

1. Received prior treatments.

2. Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).

3. Bilateral breast cancer.

4. Multiple breast cancers distributed in different quadrants.

5. Patients not suitable for neoadjuvant chemotherapy.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoadjuvant Chemotherapy
• Organoids

Intervention

Procedure:
• Biopsy
Before initiating neoadjuvant therapy, patients diagnosed with breast cancer undergo a tumor biopsy. The tissue obtained from the biopsy is utilized to establish organoids and conduct drug testing.

Locations

Country	Name	City	State
China	2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes.	The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.	2023.12-2025.06
Secondary	Comparison between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.	The sensitivity and specificity would be checked between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.	2023.12-2025.06