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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational study) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood components related to efficacy | Compare the differences in peripheral blood components between patients with different treatment efficacies. | Approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Age-related components associated with efficacy | Identify age-related peripheral blood and tissue components associated with efficacy. | Approximately 18 months |
| Age-related peripheral blood components |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of early-stage luminal breast cancer patients receiving neoadjuvant therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao, MD, PhD | Contact | +86-021-64175590 Ext. 88807 | zhimin_shao@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center Shanghai, China, 200032 | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood sample and tumor sample
Evaluate the differences in peripheral blood components between young and elderly patients.
| Approximately 18 months |
| Efficacy of neoadjuvant immunotherapy in young and elderly patients assessed by Miller-Payne grading | 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. | Approximately 18 months |
| D017437 |
| Skin and Connective Tissue Diseases |