Status:
RECRUITING
Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Organoids
Breast Cancer
Eligibility:
FEMALE
18-70 years
Brief 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 neoadjuv...
Detailed Description
58 early-stage breast cancer patients scheduled to undergo neoadjuvant therapy will be recruited. Baseline information including medical history, ultrasound, Breast-Specific Gamma Imaging (BSGI), and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06155305
Start Date
December 6 2023
End Date
December 1 2025
Last Update
January 7 2025
Active Locations (1)
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1
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009