Invasive Breast Cancer Clinical Trial
— RBC-02Official title:
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University |
China,
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 |
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