Breast CancerNCT07132502
Treatment Intermittent Periods Based on ctDNA-MRD（Circulating Tumor DNA-minimal Residual Disease） Status in Advanced HER2-Positive Breast Cancer
An observational study of Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
Breast cancer seriously threatens the health of women worldwide. The HER-2-positive subtype accounts for approximately 15% to 20%, featuring strong invasiveness and poor prognosis. In recent years, anti-HER-2 targeted therapy has developed rapidly. 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?
- ctDNA MRD
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2025to 15 Jul 2027
- 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: The population refers to patients with advanced HER-2 positive breast cancer who have achieved complete response (CR), negative ctDNA-MRD (circulating tumor DNA - minimal residual disease), and negative CA153.
Who may be able to join
- Pathologically confirmed HER-2 positive breast cancer (immunohistochemistry 3+ or 2+ with FISH positivity).Diagnosis of advanced breast cancer in accordance with AJCC staging criteria.
- Achieved complete response (CR) as evaluated by PET-CT or contrast-enhanced CT after receiving salvage therapy (within second-line) and maintained for 3 months.
- Negative ctDNA-MRD (circulating tumor DNA - minimal residual disease) detection.
- Negative CA153 detection.
- ECOG performance status score of 0-2.
- Expected survival ≥ 6 months.
- The patient has signed an informed consent form, willing to cooperate with the study and accept regular follow-up.
Who cannot join
- Concomitant other malignant tumors (excluding breast cancer).
- History of mental disorders or cognitive dysfunction, unable to cooperate with the study.
- Pregnant or lactating women.
- Severe cardiac, hepatic, or renal insufficiency.
- Currently participating in other clinical trials that may affect the evaluation of this study's results.
About this study
Official title: Treatment Intermittent Periods Based on ctDNA-MRD Status in Advanced HER2-Positive Breast Cancer: A Non-Interventional Exploratory Study
Breast cancer seriously threatens the health of women worldwide. The HER-2-positive subtype accounts for approximately 15% to 20%, featuring strong invasiveness and poor prognosis. In recent years, anti-HER-2 targeted therapy has developed rapidly. The application of various drugs has improved the remission rate of advanced patients, leading to an increase in the number of patients achieving complete remission (CR). However, CR patients still face the risk of recurrence. Moreover, treatment decisions are confronted with dilemmas such as the contradiction between the cumulative toxicity of continuous treatment and the increased risk of recurrence due to premature drug withdrawal, as well as the lack of step-down treatment guidance strategies in disease-free states.
Circulating tumor DNA (ctDNA)-mediated molecular residual disease (MRD) detection shows potential in predicting prognosis and monitoring recurrence in various solid tumors, with certain progress also made in the field of breast cancer. However, there are few studies on its application in guiding treatment decisions for advanced HER-2-positive breast cancer patients after CR.
This study adopts a prospective, observational cohort study design. It intends to screen advanced HER-2-positive breast cancer patients, include those who have achieved CR with negative ctDNA-MRD and negative CA153, and divide them into a drug intermission group and a continued salvage treatment group based on patients' autonomous choices. The study will conduct long-term follow-up on the two groups, dynamically monitor the ctDNA-MRD status, observe the disease changes when treatment is paused in the drug intermission group, as well as the treatment response and disease progression in the continued salvage treatment group. It will evaluate the impact of the drug intermission strategy on prognostic indicators such as progression-free survival (PFS) and overall survival (OS), clarify whether ctDNA-MRD can accurately predict recurrence risk to guide individualized treatment, explore the feasibility and safety of the drug intermission strategy to balance efficacy and toxicity, screen patients with good prognosis to provide a basis for step-down treatment, and promote precision treatment for advanced HER-2-positive breast cancer, filling the research gap.
- Conditions
- Breast Cancer
- Being tested
- ctDNA MRD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA MRDOther
Definition and Essence: ctDNA MRD involves detecting DNA fragments released by tumor cells into the bloodstream through highly sensitive techniques to determine the status of minimal residual disease in cancer patients.
Detection Methods: Technologies such as digital PCR and next-generation sequencing (NGS) are employed to achieve precise detection of low-frequency ctDNA mutations.
Clinical Significance: It is utilized for evaluating the prognosis of cancer patients and providing crucial evidence for the formulation of personalized treatment plans.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression - free survival (PFS)
Measured: from July 2025 to June 2027
Secondary outcomes (3)
Overall survival (OS):
Measured: from July 2025 to June 2027
Treatment - free interval
Measured: from July 2025 to June 2027
Patient quality of life assessment
specific quality of life scales such as EORTC QLQ - C30 （European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30）1.Functional domains (e.g., physical functioning, emotional functioning, etc.): A higher score indicates better functioning in that aspect (e.g., a score of 100 represents fully normal functioning, while a score of 0 indicates severe functional impairment).
2.Symptom domains (e.g., fatigue, pain, etc.) and global quality of life domain: For symptom domains, a higher score indicates more severe symptoms or poorer quality of life; for the global quality of life domain, a higher score indicates better overall quality of life.
Measured: from July 2025 to June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion8 Jul 2027 (estimated)
- Study completion15 Jul 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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132502
- Sponsor's protocol ID
- NC5269
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Intermittent Periods Based on ctDNA-MRD Status in Advanced HER2-Positive Breast Cancer: A Non-Interventional Exploratory Study
- ClinicalTrials.gov ID
- NCT07132502
- Acronym / sponsor ID
- NC5269
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 20 Aug 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.
Breast cancer seriously threatens the health of women worldwide. The HER-2-positive subtype accounts for approximately 15% to 20%, featuring strong invasiveness and poor prognosis. In recent years, anti-HER-2 targeted therapy has developed rapidly. The application of various drugs has improved the remission rate of advanced patients, leading to an increase in the number of patients achieving complete remission (CR). However, CR patients still face the risk of recurrence. Moreover, treatment decisions are confronted with dilemmas such as the contradiction between the cumulative toxicity of continuous treatment and the increased risk of recurrence due to premature drug withdrawal, as well as the lack of step-down treatment guidance strategies in disease-free states.
Circulating tumor DNA (ctDNA)-mediated molecular residual disease (MRD) detection shows potential in predicting prognosis and monitoring recurrence in various solid tumors, with certain progress also made in the field of breast cancer. However, there are few studies on its application in guiding treatment decisions for advanced HER-2-positive breast cancer patients after CR.
This study adopts a prospective, observational cohort study design. It intends to screen advanced HER-2-positive breast cancer patients, include those who have achieved CR with negative ctDNA-MRD and negative CA153, and divide them into a drug intermission group and a continued salvage treatment group based on patients' autonomous choices. The study will conduct long-term follow-up on the two groups, dynamically monitor the ctDNA-MRD status, observe the disease changes when treatment is paused in the drug intermission group, as well as the treatment response and disease progression in the continued salvage treatment group. It will evaluate the impact of the drug intermission strategy on prognostic indicators such as progression-free survival (PFS) and overall survival (OS), clarify whether ctDNA-MRD can accurately predict recurrence risk to guide individualized treatment, explore the feasibility and safety of the drug intermission strategy to balance efficacy and toxicity, screen patients with good prognosis to provide a basis for step-down treatment, and promote precision treatment for advanced HER-2-positive breast cancer, filling the research gap.
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
- The population refers to patients with advanced HER-2 positive breast cancer who have achieved complete response (CR), negative ctDNA-MRD (circulating tumor DNA - minimal residual disease), and negative CA153.
Key inclusion criteria (7 listed)
- Pathologically confirmed HER-2 positive breast cancer (immunohistochemistry 3+ or 2+ with FISH positivity).Diagnosis of advanced breast cancer in accordance with AJCC staging criteria.
- Achieved complete response (CR) as evaluated by PET-CT or contrast-enhanced CT after receiving salvage therapy (within second-line) and maintained for 3 months.
- Negative ctDNA-MRD (circulating tumor DNA - minimal residual disease) detection.
- Negative CA153 detection.
- ECOG performance status score of 0-2.
Key exclusion criteria (5 listed)
- Concomitant other malignant tumors (excluding breast cancer).
- History of mental disorders or cognitive dysfunction, unable to cooperate with the study.
- Pregnant or lactating women.
- Severe cardiac, hepatic, or renal insufficiency.
- Currently participating in other clinical trials that may affect the evaluation of this study's results.
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 |
|---|---|---|
| ctDNA MRDDefinition and Essence: ctDNA MRD involves detecting DNA fragments released by tumor cells into the bloodstream through highly sensitive techniques to determine the status of minimal residual disease in cancer patients. Detection Methods: Technologies such as digital PCR and next-generation sequencing (NGS) are employed to achieve precise detection of low-frequency ctDNA mutations. Clinical Significance: It is utilized for evaluating the prognosis of cancer patients and providing crucial evidence for the formulation of personalized treatment plans. | Other | – |
Primary outcome
Progression - free survival (PFS)
Time frame: from July 2025 to June 2027
3 secondary outcomes
Overall survival (OS):
Time frame: from July 2025 to June 2027
Treatment - free interval
Time frame: from July 2025 to June 2027
Patient quality of life assessment
Time frame: from July 2025 to June 2027
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 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 7 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Progression - free survival (PFS) (time frame: from July 2025 to June 2027). 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 20 Aug 2025.