Status:
COMPLETED
MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Therapy in Breast Cancer
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Shantou Central Hospital
The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the fir...
Detailed Description
Breast cancer is the most prevalent cancer among women worldwide. NAT has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast canc...
Eligibility Criteria
Inclusion
- For training cohort:
- Age ≥18 years;
- Histologically confirmed invasive breast carcinoma;
- Clinical stage II-III at presentation;
- Complete basic information and image data;
- Have MRI imaging data at baseline and after the first cycle of NAC;
- Finish the standard NAC treatment and undergo surgery;
Exclusion
- With chemotherapy contraindications;
- Multifocal of multicentric lesions;
- Poor quality of MRI images;
- For validation cohort:
- Inclusion Criteria:
- Age ≥18 years;
- Complete basic information and image data;
- Clinical stage II-III at presentation;
- Scheduled for neoadjuvant chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Signed informed consent;
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04909554
Start Date
January 1 2019
End Date
December 30 2023
Last Update
August 6 2024
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080