Breast CancerNCT06566729
MRD in High-risk EBC
An observational study of Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Peripheral blood sample collection
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4; 2. HER2-positive breast cancer, lymph node metastasis≥4; 3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;
Who may be able to join
- Informed consent signed
- Age ≥18 years old
- Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:
- Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
- HER2-positive breast cancer, lymph node metastasis≥4;
- Triple negative breast cancer, the number of lymph node metastases ≥ 1;
- ECOG 0-1
- Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance
Who cannot join
- Confirmed distant metastases site
- History of other malignancy
- Psychopaths or other reasons unable to comply with treatment
- Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
- HIV carrier or HBC/HCV infected
- Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.
- Conditions
- Breast Cancer
- Being tested
- Peripheral blood sample collection
- Keywords
- MRD, breast cancer, adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood sample collectionOther
In this study, peripheral blood samples would be collected before adjuvant chemotherapy, after adjuvant chemotherapy and every 3 months thereafter until 2 years after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause
Measured: 5 years after surgery
Secondary outcomes (2)
Overall survival
Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause
Measured: 5 years after surgery
Lead time
Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Jun 2023
- Primary completion30 Sep 2024 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566729
- Sponsor's protocol ID
- RJBC2301
- Status last verified
- Jun 2024
- First submitted
- 21 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06566729
- Acronym / sponsor ID
- RJBC2301
- Conditions
- Breast Cancer
- Keywords
- MRD, breast cancer, adjuvant therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Aug 2024 (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 a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4; 2. HER2-positive breast cancer, lymph node metastasis≥4; 3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;
Key inclusion criteria (8 listed)
- Informed consent signed
- Age ≥18 years old
- Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:
- ECOG 0-1
- Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance
Key exclusion criteria (6 listed)
- Confirmed distant metastases site
- History of other malignancy
- Psychopaths or other reasons unable to comply with treatment
- Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
- HIV carrier or HBC/HCV infected
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 |
|---|---|---|
| Peripheral blood sample collectionIn this study, peripheral blood samples would be collected before adjuvant chemotherapy, after adjuvant chemotherapy and every 3 months thereafter until 2 years after surgery. | Other | – |
Primary outcome
Relapse-free survival
Time frame: 5 years after surgery
Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause
2 secondary outcomes
Overall survival
Time frame: 5 years after surgery
Lead time
Time frame: 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site 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 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (time frame: 5 years after surgery). 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 22 Aug 2024.