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

Invasive Breast Cancer Clinical Trial

— RBC-02  

Official title:

Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004559
• Other study ID #: SYSEC-KY-KS-2019-055-001
• Status: Recruiting
• Start date: May 28, 2019
• Est. completion date: May 30, 2025

Study information

• Verified date: June 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, Ph. D
• Phone: +8613500018020
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 30, 2025
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Axillary Lymph Node
• Breast Neoplasms
• Invasive Breast Cancer
• Neoadjuvant Chemotherapy
• Neoplasm Metastasis
• Prognosis
• Radiomics

Intervention

Other:
• No interventions
As this is a patient registry, there are no interventions.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	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.	5 years
Secondary	pathological complete response (pCR)	The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.	Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary	Pathological axillary lymph node status	The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not.	Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary	Overall survival (OS)	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.	5 years
Secondary	Breast cancer specific motality (BCSM)	Defined as time between randomization and the time of death occur specific due to breast cancer	5 years
Secondary	Recurrence free survival (RFS)	Defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred	5 years