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

NCT04909554 | Completed DMC

• 1 other identifier: 20210504
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

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 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

Breast Cancer

Keywords

Magnetic resonance imaging (MRI); Neoadjuvant therapy (NAT); therapeutic response; breast cancer; early prediction

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.

  up to 28 weeks

Secondary Outcomes (2)

• Specificity

  up to 28 weeks

• Specificity

  up to 6 weeks

Other Outcomes (2)

• Shrinkage pattern

  up to 28 weeks

• correlation between shrinkage patterns and efficacy

  up to 28 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• With chemotherapy contraindications;
• Multifocal of multicentric lesions;
• Poor quality of MRI images;
• For validation cohort:
• 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;
• With chemotherapy contraindications;
• Metastatic breast cancer;
• Multifocal of multicentric lesions;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Shantou Central Hospital: collaborator
• The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University: collaborator
• First People's Hospital of Foshan: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Zou 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kun Kun, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: June 1, 2021
• Study Start: January 1, 2019
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)