The Association Between Age-related Peripheral Blood Components and Treatment Efficacy in Breast Cancer
NCT ID: NCT06718010
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-12-05
2026-03-31
Brief Summary
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The study population consists of early-stage HR+HER2- breast cancer patients receiving neoadjuvant therapy. Eligible patients who require neoadjuvant treatment will be enrolled in the study. Retrospective data and samples will be collected based on existing patient medical records and tissue biobank samples. Prospective data collection will be based on routine clinical treatment during the study period and will continue until the patient completes neoadjuvant therapy and undergoes primary tumor surgery, or until the study is prematurely terminated.
HR+HER2- breast cancer patients receiving neoadjuvant therapy will be divided into young and elderly groups. Peripheral blood samples will be collected at baseline (T0, prior to treatment) and after two cycles of neoadjuvant therapy (T1). Paired baseline tumor biopsy samples and/or surgical tumor samples will also be collected. Peripheral blood and tumor samples will undergo appropriate tests.
The study respects the investigator's choice of treatment, without specifying which drugs should be used, the dosage, the administration mode (including monotherapy, combination therapy, or sequential therapy), or the duration of treatment.
Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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No intervention (observational study)
The study respects the investigator's choice of treatment, without specifying which drugs should be used, the dosage, the administration mode (including monotherapy, combination therapy, or sequential therapy), or the duration of treatment.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years;
3. Female;
4. Histologically/cytologically confirmed breast cancer;
5. Determined by immunohistochemistry to be ER+ or PR+ (with at least 1% of cells expressing estrogen receptors) and HER2-.
Exclusion Criteria
2. History of other malignancies. Patients with basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers who have been disease-free for more than 5 years after appropriate treatment may be included;
3. Participation in another clinical trial within 30 days prior to starting neoadjuvant treatment for breast cancer, and receiving investigational drugs or any concomitant treatment including investigational drugs;
4. Immunodeficiency or HIV infection;
5. Severe heart, lung, liver, or kidney dysfunction;
6. Uncontrolled infections or active infections;
7. Pregnant or breastfeeding women.
18 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Locations
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Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhimin Shao, M.D.
Role: primary
Other Identifiers
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ALPHABET-001
Identifier Type: -
Identifier Source: org_study_id