Clinical trial NCT04004559: MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Breast Cancer
Neoadjuvant Chemotherapy
Radiomics
Axillary Lymph Node
Prognosis
Keywords: Invasive Breast Cancer
Neoadjuvant Chemotherapy
Radiomics
Axillary Lymph Node Metastasis
Survival
Machine Learning Analysis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Tungwah Hospital of Sun Yat-Sen University
First posted: 2019-07-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: 5 years
Secondary outcomes:
measure: pathological complete response (pCR)
timeFrame: Pathologic evaluation will be performed for each patient within 1 week after surgery
measure: Pathological axillary lymph node status
timeFrame: Pathologic evaluation will be performed for each patient within 1 week after surgery
measure: Overall survival (OS)
timeFrame: 5 years
measure: Breast cancer specific motality (BCSM)
timeFrame: 5 years
measure: Recurrence free survival (RFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Herui Yao, PhD
role: STUDY_CHAIR
affiliation: Sun Yat-sen University
name: Chuanmiao Xie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: