About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
ECOG performance status score of 0-1.
Disqualifiers
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.
Trial population
Patients with breast cancer (AJCC stages I to IIIA) who need to receive neoadjuvant therapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Biopsy
Procedure/SurgeryBefore 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.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes.
The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.
Secondary outcomes
Comparison between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.
The sensitivity and specificity would be checked between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.
Sponsors and contacts
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