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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Age
• Intervention / Treatment: Other: No intervention (observational study)

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Zhimin Shao, MD, PhD; Phone Number: +86-021-64175590 Ext. 88807; Email: zhimin_shao@yeah.net

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center Shanghai, China, 200032
      • Contact: Zhimin Shao, M.D.; Phone Number: +86-021-64175590 Ext. 88807; Email: zhimin_shao@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consists of early-stage luminal breast cancer patients receiving neoadjuvant therapy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: ALPHABET-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No