Actively Recruiting
Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-07
58
Participants Needed
1
Research Sites
103 weeks
Total Duration
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AI-Summary
What this Trial Is About
Breast cancer is the most common cancer in women worldwide, often diagnosed at later stages where breast conservation is desired. This research focuses on early-stage breast cancer patients who are scheduled for neoadjuvant chemotherapy. Because tumors vary in molecular subtype and patient response, accurately assessing how patients respond to treatment is important to improve outcomes. The study will enroll 58 female patients with early-stage breast cancer to explore this further using patient-derived organoids. Patients will undergo tumor biopsies before starting neoadjuvant chemotherapy. From these biopsies, organoids will be created and cultured. These organoids will then be treated with standard chemotherapy drugs for breast cancer, including Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, and targeted therapies like Herceptin and Pertuzumab. The growth and response of the organoids to these drugs will be measured and dose-response curves will be developed. Participants will have their medical history recorded and undergo ultrasound, Breast-Specific Gamma Imaging, and MRI before and after two chemotherapy cycles. The study will assess the tumor's histological response using the Residual Cancer Burden system. Researchers will correlate the drug sensitivity results observed in the organoid models with the patients' clinical outcomes from December 2023 to June 2025 to evaluate the consistency between lab and patient responses.
CONDITIONS
Official Title
Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or more detected by MRI and no distant metastasis (M0).
- If multiple lesions are present, the largest lesion must have a diameter of 2cm or more.
- ECOG performance status score of 0-1.
- No significant abnormalities in liver and kidney function (bilirubin <1.5 times upper limit of normal; ALT and AST <2.5 times upper limit of normal; creatinine 2 times upper limit of normal).
You will not qualify if you...
- Received prior treatments.
- Locally advanced breast cancer not suitable for surgery or inflammatory breast cancer (unresectable AJCC stage III).
- Bilateral breast cancer.
- Multiple breast cancers in different quadrants.
- Not suitable for neoadjuvant chemotherapy.
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Trial Site Locations
Total: 1 location
1
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Z
ZHIGANG CHEN
J
Jian Huang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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