Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer
Recruiting · NCT06155305 · Observational (researchers observe without assigning treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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).
Exclusion criteria
- 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
1 location listed.
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China - Hangzhou, Zhejiang, China