Age, Breast Cancer
Conditions
Brief 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.
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.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent according to local regulations; 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
1. Presence of distant metastasis; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral blood components related to efficacy | Approximately 18 months | Compare the differences in peripheral blood components between patients with different treatment efficacies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age-related components associated with efficacy | Approximately 18 months | Identify age-related peripheral blood and tissue components associated with efficacy. |
| Age-related peripheral blood components | Approximately 18 months | Evaluate the differences in peripheral blood components between young and elderly patients. |
| Efficacy of neoadjuvant immunotherapy in young and elderly patients assessed by Miller-Payne grading | Approximately 18 months | Compare the efficacy of neoadjuvant immunotherapy in young and elderly patients assessed by Miller-Payne grading. The Miller-Payne grading system is primarily used to evaluate the efficacy of neoadjuvant therapy in breast cancer. Based on the percentage of residual tumor cells, it is divided into five grades, ranging from Grade I to Grade V, with higher grades indicating a better outcome. |
Countries
China
Contacts
CONTACTZhimin Shao, MD, PhD
Outcome results
None listed