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Search / Trial NCT04909554

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

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · May 28, 2021

Trial Information

Current as of June 13, 2025

Completed

Keywords

Magnetic Resonance Imaging (Mri) Neoadjuvant Therapy (Nat) Therapeutic Response Breast Cancer Early Prediction

ClinConnect Summary

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, pros...

Gender

FEMALE

Eligibility criteria

  • 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;

About Guangdong Provincial People's Hospital

Guangdong Provincial People's Hospital is a leading tertiary healthcare institution located in Guangdong Province, China, renowned for its comprehensive medical services and advanced research capabilities. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical science through innovative research and the rigorous evaluation of new therapies and interventions. With a multidisciplinary team of experienced clinicians and researchers, the institution prioritizes patient safety and ethical standards while fostering collaborations with academic and industry partners to enhance healthcare outcomes and contribute to the global medical community.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Kun Kun, MD

Study Chair

Guangdong Provincial People's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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