Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well different chemotherapy drugs work for women with early-stage breast cancer before surgery. Researchers want to understand the effectiveness of these treatments by using tiny lab-grown versions of the patients' tumors, called organoids. This approach will help determine which chemotherapy options, like Doxorubicin and Carboplatin, or targeted therapies like Herceptin, may work best for each patient, ultimately improving treatment outcomes.

To be eligible for this study, women aged 18 to 70 with early-stage breast cancer that is at least 2cm across and suitable for surgery may participate. Participants must be in good overall health, without significant liver or kidney issues, and should not have received prior treatments for their cancer. Those who join the trial will provide a small sample of their tumor for testing and will have their responses to the chemotherapy monitored. This trial aims to personalize breast cancer treatment and support better decision-making for patients and their doctors.

Gender

FEMALE

Eligibility criteria

• 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.