Breast CancerNCT07574749
Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to learn if a new diagnostic test using specific labels for breast cancer sEVs on a microchip can accurately diagnose the molecular subtypes in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to 30 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced breast cancer
Who may be able to join
- Age 18-75 years (inclusive)
- ECOG performance status 0-1
- Life expectancy ≥3 months
- Unresectable or metastatic breast cancer
- Core needle biopsy of recurrent/metastatic lesions is ongoing or planned before initiating new treatment regimen, with provision of fresh tumor tissue specimens and collection of peripheral blood samples
- Per RECIST v1.1 criteria, at least one measurable lesion or bone-only metastases
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- Adequate bone marrow reserve and organ function prior to first dose:
- Bone marrow reserve: Platelet count (PLT) ≥90 × 10⁹/L, absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, hemoglobin ≥9 g/dL
- Coagulation function: INR ≤1.5, APTT ≤1.5 × ULN
- Hepatic function: Basically normal liver function, total bilirubin ≤1.5 × ULN (patients with Gilbert's syndrome may have total bilirubin ≤3 × ULN), AST and ALT ≤2.5 × ULN (if liver metastases are present, AST and ALT ≤5 × ULN)
- Renal function: Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula)
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤470 ms for females, ≤450 ms for males Able to communicate effectively with the investigator and understand and comply with all requirements of the study -
Who cannot join
- Receipt of radiotherapy, chemotherapy, traditional Chinese medicine with anti-tumor indications, or local therapy (interventional treatment but excluding tumor biopsy, ablation therapy, etc.) within 2 weeks prior to enrollment
- Adverse reactions from previous anti-tumor treatment not recovered to ≤Grade 1 per CTCAE v5.0 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, long-term toxicities from radiotherapy, or other toxicities ≤Grade 2)
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
- Uncontrolled or serious medical conditions, including but not limited to active infections requiring systemic antibiotic therapy
- History of serious cardiovascular or cerebrovascular diseases, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.
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- Class III-IV cardiac dysfunction per New York Heart Association (NYHA) criteria
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular or cerebrovascular events within 6 months prior to first dose
- Clinically uncontrolled hypertension
- Any factors that increase the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, or use of any concomitant medications known or suspected to prolong the QT interval
- History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation
- HIV infection, active HBV or HCV infection; the following situations are allowed for enrollment:
- Patients positive for hepatitis B surface antigen (HBsAg), with or without positive hepatitis B core antibody (anti-HBc), if HBV DNA <500 IU/mL or below the lower limit of the study site's reference range, and active infection is ruled out by the investigator based on clinical treatment, presentation, etc.
- Patients positive for hepatitis C (HCV) antibody when HCV RNA is negative
- Females of childbearing potential with positive pregnancy test within 7 days prior to first dose or who are lactating
- Known psychiatric illness or disorder that may affect study compliance
- Other conditions judged by the investigator to be unsuitable for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ting Li contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hongxia wang, PHD, 021-64175590, whx365@126.com
whx365@126.com
About this study
Official title: Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy: An Exploratory, Single-Center, Phase II Clinical Study
The goal of this observational study is to learn if a new diagnostic test using specific labels for breast cancer sEVs on a microchip can accurately diagnose the molecular subtypes in patients with breast cancer. The main questions it aims to answer are:
- What is the sensitivity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes?
- What is the specificity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes? Researchers will compare the results from the new sEVs panel to the results from the standard pathological diagnosis to see if the new panel is accurate and reliable.
Read more
Participants will be asked to:
- Provide blood samples and tissue samples.
- Allow researchers to access their clinical data, such as their diagnosis, treatment information, and outcomes.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1（Model Building Cohort） | Not described | |
| Phase 1（Model Building Cohort）, Phase 2（External Validation Cohort） | Phase 1（Model Building Cohort）: 500 participants will be enrolled to construct a classifier composed of sEVs molecules as a predictive model for molecular subtyping. Phase 2（External Validation Cohort）: 1,000 participants will be enrolled to evaluate the sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis compared with classical pathological molecular subtyping diagnosis using ROC curves and other tools. This phase will delineate the distribution of sEVs molecular subtypes and explore the correlation between sEVs molecular subtypes and the efficacy of treatment regimens selected by physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis
Measured: From baseline through treatment completion, up to 36 months
Secondary outcomes (5)
Distribution of sEVs molecular subtypes
Distribution of sEVs molecular subtypes
Measured: From baseline through treatment completion, up to 36 months
Correlation analysis between sEVs molecular subtypes and drug efficacy
Correlation analysis between sEVs molecular subtypes and drug efficacy
Measured: From baseline through treatment completion, up to 36 months
PFS (Progression-Free Survival)
Time from start of treatment to the first documented disease progression per RECIST v1.1 or death due to any cause.
Measured: From treatment initiation until progression or death, up to 36 months
Overall Survival (OS) and Objective Response Rate (ORR)
Objective Response Rate (ORR): As assessed according to the RESIST 1.1 criteria, with complete response (CR) and partial response (PR) combined to define a response.
Overall Survival (OS): The time from enrolment to death from any cause; for lost-to-follow-up patients, survival is calculated as of the date of the last follow-up visit, and these are treated as censored data.
Measured: From treatment initiation until progression or death , up to 36 months
Safety and Tolerability of Physician-Selected Treatment Regimens
All subjects shall undergo toxicity assessment from the start of their first treatment, with toxicity assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From treatment initiation until 30 days after the last dose, or until the initiation of a new antineoplastic therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start7 Apr 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion30 Jul 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.
- More trials run by Fudan 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574749
- Sponsor's protocol ID
- sEVs-ABC-IIT-001
- Status last verified
- Oct 2025
- First submitted
- 2 Feb 2026
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy: An Exploratory, Single-Center, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07574749
- Acronym / sponsor ID
- sEVs-ABC-IIT-001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 8 May 2026 (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.
The goal of this observational study is to learn if a new diagnostic test using specific labels for breast cancer sEVs on a microchip can accurately diagnose the molecular subtypes in patients with breast cancer. The main questions it aims to answer are:
- What is the sensitivity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes?
- What is the specificity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes? Researchers will compare the results from the new sEVs panel to the results from the standard pathological diagnosis to see if the new panel is accurate and reliable.
Participants will be asked to:
- Provide blood samples and tissue samples.
- Allow researchers to access their clinical data, such as their diagnosis, treatment information, and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1（Model Building Cohort） | – | – |
| Phase 1（Model Building Cohort）, Phase 2（External Validation Cohort） | – | –Phase 1（Model Building Cohort）: 500 participants will be enrolled to construct a classifier composed of sEVs molecules as a predictive model for molecular subtyping. Phase 2（External Validation Cohort）: 1,000 participants will be enrolled to evaluate the sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis compared with classical pathological molecular subtyping diagnosis using ROC curves and other tools. This phase will delineate the distribution of sEVs molecular subtypes and explore the correlation between sEVs molecular subtypes and the efficacy of treatment regimens selected by physicians. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced breast cancer
Key inclusion criteria (12 listed)
- Age 18-75 years (inclusive)
- ECOG performance status 0-1
- Life expectancy ≥3 months
- Unresectable or metastatic breast cancer
- Core needle biopsy of recurrent/metastatic lesions is ongoing or planned before initiating new treatment regimen, with provision of fresh tumor tissue specimens and collection of peripheral blood samples
Key exclusion criteria (17 listed)
- Receipt of radiotherapy, chemotherapy, traditional Chinese medicine with anti-tumor indications, or local therapy (interventional treatment but excluding tumor biopsy, ablation therapy, etc.) within 2 weeks prior to enrollment
- Adverse reactions from previous anti-tumor treatment not recovered to ≤Grade 1 per CTCAE v5.0 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, long-term toxicities from radiotherapy, or other toxicities ≤Grade 2)
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
- Uncontrolled or serious medical conditions, including but not limited to active infections requiring systemic antibiotic therapy
- History of serious cardiovascular or cerebrovascular diseases, including but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis
Time frame: From baseline through treatment completion, up to 36 months
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis
5 secondary outcomes
Distribution of sEVs molecular subtypes
Time frame: From baseline through treatment completion, up to 36 months
Correlation analysis between sEVs molecular subtypes and drug efficacy
Time frame: From baseline through treatment completion, up to 36 months
PFS (Progression-Free Survival)
Time frame: From treatment initiation until progression or death, up to 36 months
Overall Survival (OS) and Objective Response Rate (ORR)
Time frame: From treatment initiation until progression or death , up to 36 months
Safety and Tolerability of Physician-Selected Treatment Regimens
Time frame: From treatment initiation until 30 days after the last dose, or until the initiation of a new antineoplastic therapy, whichever occurs first.
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 8 May 2026.
- 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.
Ting Li contact
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 Fudan 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 12 inclusion and 17 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 8 May 2026. 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 Xiahong Wang (8613524491606, whx365@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis (time frame: From baseline through treatment completion, up to 36 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 8 May 2026.