Clinical trial NCT04909554: MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Therapy in Breast Cancer
Official title: MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer (NeoMDSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Magnetic resonance imaging (MRI)
Neoadjuvant therapy (NAT)
therapeutic response
breast cancer
early prediction
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Shantou Central Hospital
name: The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
name: First People's Hospital of Foshan
First posted: 2021-06-01
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Selection of patients diagnosed with breast cancer and treated with neoadjuvant chemotherapy

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.

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.

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;

Primary outcomes:
measure: Sensitivity
timeFrame: up to 28 weeks
Secondary outcomes:
measure: Specificity
timeFrame: up to 28 weeks
measure: Specificity
timeFrame: up to 6 weeks
Other outcomes:
measure: Shrinkage pattern
timeFrame: up to 28 weeks
measure: correlation between shrinkage patterns and efficacy
timeFrame: up to 28 weeks
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Kun, MD
role: STUDY_CHAIR
References: