Invasive Breast CancerRBC-02NCT04004559
MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)
An observational study of Invasive Breast Cancer and Neoadjuvant Chemotherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Invasive Breast Cancer, Neoadjuvant Chemotherapy, Radiomics
- How many people
- 600 participants
- Where
- 3 sitesChina
- Study dates
- 28 May 2019to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery
Who may be able to join
- Primary lesion diagnosed as invasive breast cancer;
- Imaging examination confirmed no distant organ metastasis;
- Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
- Completed breast MRI examination before or after neoadjuvant chemotherapy;
- Accepted breast cancer surgery and axillary lymph node dissection;
- Eastern Cooperative Oncology Group performance status 0-2.
Who cannot join
- History of ipsilateral axillary or breast surgery;
- Inflammatory breast cancer;
- Bilateral breast cancer;
- Malignant tumor history in 5 years;
- Patients with cervical or contralateral axillary lymph node metastasis;
- Incomplete imaging or medical history data.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Chuanmiao Xie, PhD, +8618903050011, xiechm@sysucc.org.cn
Chuanmiao Xie, PhD
- Not yet recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
Haotian Lin, PhD, +8613802793086, gddlht@aliyun.com
Haotian Lin, PhD
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120
Herui Yao, PhD, +8613500018020, yaoherui@mail.sysu.edu.cn
Yunfang Yu, MD, +8613660238987, yuyf9@mail.sysu.edu.cn
About this study
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)
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.
Read the 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.
- Conditions
- Invasive Breast Cancer, Neoadjuvant Chemotherapy, Radiomics, Axillary Lymph Node, Prognosis
- Being tested
- No interventions
- Keywords
- Invasive Breast Cancer, Neoadjuvant Chemotherapy, Radiomics, Axillary Lymph Node Metastasis, Survival, Machine Learning Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
As this is a patient registry, there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No interventions | |
| Sun Yat-sen University Cancer Center | Cohort of Sun Yat-sen University Cancer Center is validation cohort 1. Receives: Other: No interventions | |
| Tungwah Hospital of Sun Yat-Sen University | Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
pathological complete response (pCR)
The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.
Measured: 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.
Measured: Pathologic evaluation will be performed for each patient within 1 week after surgery
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.
Measured: 5 years
Breast cancer specific motality (BCSM)
Defined as time between randomization and the time of death occur specific due to breast cancer
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start28 May 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University
- Responsible party
- Principal investigator, Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Herui Yao, PhD, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityChuanmiao Xie, PhD, Principal investigator, Sun Yat-sen UniversityHaotian Lin, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004559
- Sponsor's protocol ID
- SYSEC-KY-KS-2019-055-001
- Acronym
- RBC-02
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04004559
- Acronym / sponsor ID
- RBC-02 / SYSEC-KY-KS-2019-055-001
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | – | Other: No interventionsCohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort. |
| Sun Yat-sen University Cancer Center | – | Other: No interventionsCohort of Sun Yat-sen University Cancer Center is validation cohort 1. |
| Tungwah Hospital of Sun Yat-Sen University | – | Other: No interventionsCohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery
Key inclusion criteria (6 listed)
- Primary lesion diagnosed as invasive breast cancer;
- Imaging examination confirmed no distant organ metastasis;
- Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
- Completed breast MRI examination before or after neoadjuvant chemotherapy;
- Accepted breast cancer surgery and axillary lymph node dissection;
Key exclusion criteria (6 listed)
- History of ipsilateral axillary or breast surgery;
- Inflammatory breast cancer;
- Bilateral breast cancer;
- Malignant tumor history in 5 years;
- Patients with cervical or contralateral axillary lymph node metastasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsAs this is a patient registry, there are no interventions. | Other | Sun Yat-Sen Memorial Hospital of Sun Yat-sen University, Sun Yat-sen University Cancer Center, Tungwah Hospital of Sun Yat-Sen University |
Primary outcome
Disease free survival (DFS)
Time frame: 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.
5 secondary outcomes
pathological complete response (pCR)
Time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Pathological axillary lymph node status
Time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Overall survival (OS)
Time frame: 5 years
Breast cancer specific motality (BCSM)
Time frame: 5 years
Recurrence free survival (RFS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herui Yao, PhD study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Chuanmiao Xie, PhD principal investigator
Sun Yat-sen University
Haotian Lin, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer and Neoadjuvant Chemotherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herui Yao, Ph. D (+8613500018020, yaoherui@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.