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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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).

Locations
Other Locations
China
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITING
Hangzhou
Contact Information
Primary
ZHIGANG CHEN
chenzg@zju.edu.cn
+8657189713716
Backup
Jian Huang
drhuangjian@zju.edu.cn
+8657189713716
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 58
Treatments
Breast cancer patients
Patients diagnosed with breast cancer undergo biopsy before initiating neoadjuvant therapy.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov