RecruitingNCT06718010

The Association Between Age-related Peripheral Blood Components and Treatment Efficacy in Breast Cancer

Age-Related Peripheral Blood Components and Their Association With Treatment Efficacy in Breast Cancer Patients: An Observational Cohort Study


Sponsor

Fudan University

Enrollment

120 participants

Start Date

Dec 5, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a single-center, prospective/retrospective, observational clinical research designed to compare the differences in peripheral blood components between young and elderly HR+HER2- breast cancer patients, and to identify peripheral blood components that may affect the prognosis of young HR+HER2- breast cancer patients. 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how age-related changes in blood may affect how well breast cancer treatment works. Researchers will analyze blood samples to see if certain blood markers in older patients predict better or worse responses to treatment. **You may be eligible if...** - You are female, aged 18 or older - You have been diagnosed with breast cancer confirmed by biopsy or lab testing - Your breast cancer is hormone receptor positive (ER+ or PR+) and HER2 negative — your doctor can tell you this - You have signed informed consent **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastasis) - You have had another type of cancer (with some exceptions for cancers fully treated more than 5 years ago) - You joined another clinical trial within the past 30 days - You have HIV or a weakened immune system - You have serious heart, lung, liver, or kidney problems - You have an uncontrolled or active infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo 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.


Locations(1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

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NCT06718010


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