Clinical trial · Observational
MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Therapy in Breast Cancer
MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer (NeoMDSS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 therapy (NAT) 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- the training cohort
- description
- From January 2019 to December 2020, 140 patients from Guangdong Province People's Hospital with complete clinicopathological information and available images of MRI before treatment and after 1st-NAT were retrospectively recruited for the training cohort
- label
- the internal validation cohort
- description
- From June 2021 and December 2023, 120 patients from Guangdong Province People's Hospital were prospectively recruited for the internal validation cohort.
- label
- the external validation cohort
- description
- From June 2021 and December 2023, 41 patients from Shantou Central Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University and The First People's Hospital of Foshan were prospectively recruited for the external validation cohort.
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- up to 28 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
1. For training cohort: 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 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; Exclusion Criteria: * With chemotherapy contraindications; * Metastatic breast cancer; * Multifocal of multicentric lesions;
References
Publications (1)
- DERIVEDZou J, Zhang L, Chen Y, Lin Y, Cheng M, Zheng X, Zhuang X, Wang K. Neoadjuvant Chemotherapy and Neoadjuvant Chemotherapy With Immunotherapy Result in Different Tumor Shrinkage Patterns in Triple-Negative Breast Cancer. J Breast Cancer. 2024 Feb;27(1):27-36. doi: 10.4048/jbc.2023.0136. Epub 2023 Nov 17. PMID 37985386