MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

Recruiting

• Conditions: Invasive Breast Cancer; Prognosis; Neoadjuvant Chemotherapy; Radiomics; Axillary Lymph Node

• Registration Number: NCT04004559
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer.

Detailed Description

This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.

Study Timeline

• Study Start: 2019-05-28
• Study First Submitted: 2019-06-30
• Study First Submitted QC: 2019-06-30
• Study First Posted: 2019-07-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29
• Primary Completion: 2020-10-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

1. Primary lesion diagnosed as invasive breast cancer;
2. Imaging examination confirmed no distant organ metastasis;
3. Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
4. Completed breast MRI examination before or after neoadjuvant chemotherapy;
5. Accepted breast cancer surgery and axillary lymph node dissection;
6. Eastern Cooperative Oncology Group performance status 0-2.

Exclusion Criteria

1. History of ipsilateral axillary or breast surgery;
2. Inflammatory breast cancer;
3. Bilateral breast cancer;
4. Malignant tumor history in 5 years;
5. Patients with cervical or contralateral axillary lymph node metastasis;
6. Incomplete imaging or medical history data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	5 years	The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.

Secondary Outcome Measures

Name	Time	Method
pathological complete response (pCR)	Pathologic evaluation will be performed for each patient within 1 week after surgery	The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.
Overall survival (OS)	5 years	The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
Breast cancer specific motality (BCSM)	5 years	Defined as time between randomization and the time of death occur specific due to breast cancer
Pathological axillary lymph node status	Pathologic evaluation will be performed for each patient within 1 week after surgery	The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not.
Recurrence free survival (RFS)	5 years	Defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

Trial Locations

Locations (3)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Ophthalmic Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China