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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Breast Cancer; Prognosis; Neoadjuvant Chemotherapy; Radiomics; Axillary Lymph Node
• Intervention / Treatment: Other: No interventions

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Yunfang Yu, MD; Phone Number: +8613660238987; Email: yuyf9@mail.sysu.edu.cn
• Study Contact Backup: Name: Herui Yao, Ph. D; Phone Number: +8613500018020; Email: yaoherui@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Chuanmiao Xie, PhD; Phone Number: +8618903050011; Email: xiechm@sysucc.org.cn
      • Principal Investigator: Chuanmiao Xie, PhD
      • Sub-Investigator: Nian Lu, MD
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Herui Yao, PhD; Phone Number: +8613500018020; Email: yaoherui@mail.sysu.edu.cn
      • Contact: Yunfang Yu, MD; Phone Number: +8613660238987; Email: yuyf9@mail.sysu.edu.cn
      • Sub-Investigator: Kai Chen, MD
      • Sub-Investigator: Yunfang Yu, MD
      • Sub-Investigator: Chenchen Li, MD
    • Guangzhou, Guangdong, China, 510060
      • Not yet recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Haotian Lin, PhD; Phone Number: +8613802793086; Email: gddlht@aliyun.com
      • Sub-Investigator: Wenben Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University; Cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort.	Other: No interventions; As this is a patient registry, there are no interventions.
Sun Yat-sen University Cancer Center; Cohort of Sun Yat-sen University Cancer Center is validation cohort 1.	Other: No interventions; As this is a patient registry, there are no interventions.
Tungwah Hospital of Sun Yat-Sen University; Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2.	Other: No interventions; As this is a patient registry, there are no interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Breast cancer specific motality (BCSM)	Defined as time between randomization and the time of death occur specific due to breast cancer	5 years
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Sun Yat-sen University; Tungwah Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Chuanmiao Xie, PhD, Sun Yat-sen University; Principal Investigator: Haotian Lin, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: June 30, 2019
• First Submitted That Met QC Criteria: June 30, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Survival; Neoadjuvant Chemotherapy; Invasive Breast Cancer; Radiomics; Axillary Lymph Node Metastasis; Machine Learning Analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: SYSEC-KY-KS-2019-055-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Requests for the individual data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, and the requestor is willing to sign a data access agreement. Contact is though the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No