Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy

NCT07574749 | Recruiting

• 1 other identifier: sEVs-ABC-IIT-001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline through treatment completion, up to 36 months

Secondary Outcomes (5)

• Distribution of sEVs molecular subtypes

  From baseline through treatment completion, up to 36 months

• Correlation analysis between sEVs molecular subtypes and drug efficacy

  From baseline through treatment completion, up to 36 months

• PFS (Progression-Free Survival)

  From treatment initiation until progression or death, up to 36 months

• Overall Survival (OS) and Objective Response Rate (ORR)

  From treatment initiation until progression or death , up to 36 months

• Safety and Tolerability of Physician-Selected Treatment Regimens

  From treatment initiation until 30 days after the last dose, or until the initiation of a new antineoplastic therapy, whichever occurs first.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced breast cancer

You may qualify if:

• 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
• 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 -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiahong Wang

CONTACT

8613524491606; whx365@126.com

Ting Li

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of medical oncology department

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: May 8, 2026
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 8, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)