Breast Cancer Clinical Trial
— NeoMDSSOfficial title:
An MRI-based, Multi-parametric Model for Early Prediction of Pathological Complete Response After the First Cycle of Neoadjuvant Chemotherapy in Breast Cancer: a Multicenter, Prospective Cohort Study
NCT number | NCT04909554 |
Other study ID # | 20210504 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | June 30, 2023 |
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 first cycle of neoadjuvant chemotherapy (NAC) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 1. For training set: Inclusion Criteria: - 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 Criteria: - With chemotherapy contraindications; - Multifocal of multicentric lesions; - Poor quality of MRI images; 2. For validation set: 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; Exclusion Criteria: - With chemotherapy contraindications; - Metastatic breast cancer; - Multifocal of multicentric lesions; |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Shrinkage pattern | The difference in tumor regression shrinkage patterns between the different treatment groups. Based on the MRI after the first cycle, the tumor SPs were grouped into three categories: CS, diffuse decrease, and no change or enlargement. | up to 28 weeks | |
Other | correlation between shrinkage patterns and efficacy | The correlation between tumor regression shrinkage patterns and treatment efficacy. | up to 28 weeks | |
Primary | Sensitivity | Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve. | up to 28 weeks | |
Secondary | Specificity | Testing the sensitivity of NeoMDSS model to predict non-pCR using the area under receiver operating characteristic curve. | up to 28 weeks | |
Secondary | Specificity | Testing the difference in the tumor shrinkage patterns on magnetic resonance imaging (MRI) in triple-negative breast cancer patients receiving neoadjuvant therapy , as well as the correlation between tumor regression pattern and efficacy. | up to 6 weeks |
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