RecruitingNCT06155305

Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

58 participants

Start Date

Dec 6, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Neoadjuvant Chemotherapy Organoids

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

Signed informed consent form and willingness to participate in the clinical study.
Female patients aged between 18 and 70 years old.
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.
ECOG performance status score of 0-1.
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 Criteria5

Received prior treatments.
Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).
Bilateral breast cancer.
Multiple breast cancers distributed in different quadrants.
Patients not suitable for neoadjuvant chemotherapy.

Interventions

PROCEDUREBiopsy

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.