MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Therapy in Breast Cancer (NeoMDSS)

MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer (NeoMDSS)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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 cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAT is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients.

This is a multicenter, prospective cohort study of 301 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAT in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment.

1. Collecting MRI images data, clinical and pathological information, treatment regimens, and curative effect information to build an MRI-based, multi-parametric model.
2. Evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (ROC) curve, the area under the curve (AUC), discrimination and calibration measures.

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Selection of patients diagnosed with breast cancer and treated with neoadjuvant chemotherapy

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
the training cohort; 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
the internal validation cohort; From June 2021 and December 2023, 120 patients from Guangdong Province People's Hospital were prospectively recruited for the internal validation cohort.
the external validation cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.	up to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Testing the sensitivity of NeoMDSS model to predict non-pCR using the area under receiver operating characteristic curve.	up to 28 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
correlation between shrinkage patterns and efficacy	The correlation between tumor regression shrinkage patterns and treatment efficacy.	up to 28 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: First People's Hospital of Foshan; Shantou Central Hospital; The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
• Investigators: Study Chair: Kun Kun, MD, Guangdong Provincial People'S Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; Magnetic resonance imaging (MRI); therapeutic response; early prediction; Neoadjuvant therapy (NAT)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20210504

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No