Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2023-12-06
Last updated
2025-01-07
Condition(s) studied
OrganoidsBreast CancerNeoadjuvant Chemotherapy
Investigational drug(s) / intervention(s)
Biopsy
Biopsy: 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.
Study 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
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes. — 2023.12-2025.06 The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.
Trial sites (1)
Facility
City
Region
Status
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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