Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Thera… (NCT07574749) | Clinical Trial Compass
RecruitingNot Applicable
Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy
China1,500 participantsStarted 2025-04-07
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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)
What they're measuring
1
Sensitivity and specificity of sEVs-specific markers for breast cancer molecular subtyping diagnosis
Timeframe: From baseline through treatment completion, up to 36 months
✕. 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:
✕. 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:
✕. Females of childbearing potential with positive pregnancy test within 7 days prior to first dose or who are lactating