Breast CancerNCT06918262
Observational Clinical Study on Role of MRD in Predicting Local Therapy in Oligometastatic Breast Cancer
An observational study of Breast Cancer and MRD, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is an observational clinical study of MRD as a predictor of local treatment in patients with oligometastatic breast cancer. The aim of the study is to assess the correlation between MRD levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment in order to identify the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, MRD
- What is being tested?
- local treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Oct 2027
- How long will I take part?
- 7 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The overall study proposes to enrol patients with no more than five lesions of systemic metastases from breast cancer, which may not be confined to the same organ (with the exception of brain metastases), who have stable control of systemic disease, and who are proposed to be treated locally.
Who may be able to join
- Histologically or cytologically confirmed breast cancer.
- Previously confirmed metastatic breast cancer by imaging.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2. (4) Age ≥ 18 years at the time of signing the informed consent form. (5) Subjects willing and able to comply with the study protocol throughout the study period.
- Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study.
- Voluntarily agree to and sign a written informed consent form and be willing and able to comply with all aspects of the trial protocol, which can be withdrawn by the patient at any time without prejudice.
Who cannot join
- Patients with active/refractory infections that require ongoing anti-infective therapy.
- Severe cardiovascular compromise (history of congestive heart failure greater than New York Heart Association (NYHA) class II), unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.
- Subjects with allogeneic organ transplants requiring immunosuppressive therapy. (4) Subjects known to be human immunodeficiency virus (HIV) positive.
- 5) Subjects with a prior malignancy other than breast cancer, cervical cancer in situ, and non-melanoma skin cancer, unless the prior malignancy has been previously diagnosed and definitively treated for at least 5 years without evidence of subsequent recurrence.
- 6) Any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Zheng Lv, 18844173475, 826871727@qq.com
About this study
Official title: An Observational Clinical Study to Evaluate the Role of MRD in the Prediction of Local Therapy in Patients With Oligometastatic Breast Cancer.
This is an observational clinical study of MRD as a predictor of local treatment in patients with oligometastatic breast cancer. The aim of the study is to assess the correlation between MRD levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment in order to identify the population that would benefit from local treatment and to develop an individualised treatment plan. Subjects will agree to participate in this study and will be asked to collect as much medical history and demographic information as possible prior to enrolment to confirm that they meet the inclusion/exclusion criteria, and that they will undergo imaging and MRD testing prior to their first study treatment. Furthermore, subjects will undergo tumour imaging and MRD testing every 3 months (±7 days) after MRD treatment for the duration of the study, with additional investigations or more frequent tumour imaging evaluations as clinically indicated during the study.
Read the detailed description
This is an observational study to investigate the correlation between MRD levels and prognosis in patients with locally treated oligometastases of breast cancer, who have no more than 5 systemic metastases of breast cancer, which may not be confined to the same organ (with the exception of brain metastases), and who have stable systemic control of the disease, and who are to undergo localised treatment. Subjects will read and fully consider the \"Informed Consent Form\" for this study, sign it in writing if they decide to participate in the study, and complete the Screening Visit no later than 28 days prior to the start of study treatment. For ethical reasons, the screening visit may not be repeated if it was performed prior to the signing of the Informed Consent Form. Subjects were asked to complete imaging and MRD testing prior to their first study treatment, and to undergo on-tumour imaging and MRD testing every 3 months (±7 days) for the duration of the study, and additional investigations or more frequent on-tumour imaging evaluations could be performed during the study based on clinical indications. During this period, subjects continued study treatment until disease progression occurred, toxicity was intolerable, the subject voluntarily withdrew informed consent, or the investigator determined that the subject needed to withdraw from the study. Subjects with disease progression or early withdrawal were also required to complete an exit visit and then enter safety follow-up.
- Conditions
- Breast Cancer, MRD
- Being tested
- local treatment
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local treatmentDiagnostic test
Tumour somatic mutations were identified by 1021 panel sequencing of tumour tissues from cancer patients, and up to 20 mutations were selected as follow-up monitoring loci based on the tumour somatic variants of the patients, and a personalised panel was designed and customised.Post-operative blood from patients was analysed for recurrence risk stratification and drug indications using a combination of personalised panel and a cancer-specific core panel (~5 kb) stacked on top of each other. The postoperative blood of patients was subjected to cfDNA targeted capture and ultra-high depth NGS sequencing (\>100,000×) to analyse the status of the surveillance loci in the peripheral blood for recurrence risk stratification and medication advice.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
It is the time from local treatment of oligometastatic breast cancer to disease recurrence or death from any cause (whichever occurs first)
Measured: From enrollment to the end of treatment at 7 months
Secondary outcomes (1)
OS
It is the period from the date of randomisation until the date of the first confirmation of objective disease progression (as evaluated by the investigator in accordance with RECIST 1.1) or death from any cause (whichever occurs first)
Measured: From enrollment to the end of treatment at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Oct 2027 (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.
- More trials run by The First Hospital of Jilin 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918262
- Sponsor's protocol ID
- 24K013-001
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study to Evaluate the Role of MRD in the Prediction of Local Therapy in Patients With Oligometastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT06918262
- Acronym / sponsor ID
- 24K013-001
- Conditions
- Breast Cancer, MRD
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Apr 2025 (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 is an observational clinical study of MRD as a predictor of local treatment in patients with oligometastatic breast cancer. The aim of the study is to assess the correlation between MRD levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment in order to identify the population that would benefit from local treatment and to develop an individualised treatment plan. Subjects will agree to participate in this study and will be asked to collect as much medical history and demographic information as possible prior to enrolment to confirm that they meet the inclusion/exclusion criteria, and that they will undergo imaging and MRD testing prior to their first study treatment. Furthermore, subjects will undergo tumour imaging and MRD testing every 3 months (±7 days) after MRD treatment for the duration of the study, with additional investigations or more frequent tumour imaging evaluations as clinically indicated during the study.
Detailed description
This is an observational study to investigate the correlation between MRD levels and prognosis in patients with locally treated oligometastases of breast cancer, who have no more than 5 systemic metastases of breast cancer, which may not be confined to the same organ (with the exception of brain metastases), and who have stable systemic control of the disease, and who are to undergo localised treatment. Subjects will read and fully consider the \"Informed Consent Form\" for this study, sign it in writing if they decide to participate in the study, and complete the Screening Visit no later than 28 days prior to the start of study treatment. For ethical reasons, the screening visit may not be repeated if it was performed prior to the signing of the Informed Consent Form. Subjects were asked to complete imaging and MRD testing prior to their first study treatment, and to undergo on-tumour imaging and MRD testing every 3 months (±7 days) for the duration of the study, and additional investigations or more frequent on-tumour imaging evaluations could be performed during the study based on clinical indications. During this period, subjects continued study treatment until disease progression occurred, toxicity was intolerable, the subject voluntarily withdrew informed consent, or the investigator determined that the subject needed to withdraw from the study. Subjects with disease progression or early withdrawal were also required to complete an exit visit and then enter safety follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The overall study proposes to enrol patients with no more than five lesions of systemic metastases from breast cancer, which may not be confined to the same organ (with the exception of brain metastases), who have stable control of systemic disease, and who are proposed to be treated locally.
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed breast cancer.
- Previously confirmed metastatic breast cancer by imaging.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2. (4) Age ≥ 18 years at the time of signing the informed consent form. (5) Subjects willing and able to comply with the study protocol throughout the study period.
- Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study.
- Voluntarily agree to and sign a written informed consent form and be willing and able to comply with all aspects of the trial protocol, which can be withdrawn by the patient at any time without prejudice.
Key exclusion criteria (5 listed)
- Patients with active/refractory infections that require ongoing anti-infective therapy.
- Severe cardiovascular compromise (history of congestive heart failure greater than New York Heart Association (NYHA) class II), unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.
- Subjects with allogeneic organ transplants requiring immunosuppressive therapy. (4) Subjects known to be human immunodeficiency virus (HIV) positive.
- 5) Subjects with a prior malignancy other than breast cancer, cervical cancer in situ, and non-melanoma skin cancer, unless the prior malignancy has been previously diagnosed and definitively treated for at least 5 years without evidence of subsequent recurrence.
- 6) Any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for entry into the study.
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 |
|---|---|---|
| local treatmentTumour somatic mutations were identified by 1021 panel sequencing of tumour tissues from cancer patients, and up to 20 mutations were selected as follow-up monitoring loci based on the tumour somatic variants of the patients, and a personalised panel was designed and customised.Post-operative blood from patients was analysed for recurrence risk stratification and drug indications using a combination of personalised panel and a cancer-specific core panel (~5 kb) stacked on top of each other. The postoperative blood of patients was subjected to cfDNA targeted capture and ultra-high depth NGS sequencing (\>100,000×) to analyse the status of the surveillance loci in the peripheral blood for recurrence risk stratification and medication advice. | Diagnostic test | – |
Primary outcome
PFS
Time frame: From enrollment to the end of treatment at 7 months
It is the time from local treatment of oligometastatic breast cancer to disease recurrence or death from any cause (whichever occurs first)
1 secondary outcome
OS
Time frame: From enrollment to the end of treatment at 7 months
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 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
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 and MRD, run by The First Hospital of Jilin University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
Contact Zheng Lv (+8618844173475, 826871727@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From enrollment to the end of treatment at 7 months). 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 9 Apr 2025.