Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Recruiting now

Conditions studied: Organoids, Breast Cancer, Neoadjuvant Chemotherapy

In brief

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.

Key facts

Study ID

NCT06155305

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

58

Starts

2023-12-06

Expected to finish

2025-12-01

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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