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

NCT06718010 | Recruiting

• 1 other identifier: ALPHABET-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Age

Outcome Measures

Primary Outcomes (1)

• Peripheral blood components related to efficacy

  Compare the differences in peripheral blood components between patients with different treatment efficacies.

  Approximately 18 months

Secondary Outcomes (3)

• Age-related components associated with efficacy

  Approximately 18 months

• Age-related peripheral blood components

  Approximately 18 months

• Efficacy of neoadjuvant immunotherapy in young and elderly patients assessed by Miller-Payne grading

  Approximately 18 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Signed informed consent according to local regulations;
• Age ≥ 18 years;
• Female;
• Histologically/cytologically confirmed breast cancer;
• Determined by immunohistochemistry to be ER+ or PR+ (with at least 1% of cells expressing estrogen receptors) and HER2-.

You may not qualify if:

• Presence of distant metastasis;
• 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;
• 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;
• Immunodeficiency or HIV infection;
• Severe heart, lung, liver, or kidney dysfunction;
• Uncontrolled infections or active infections;
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and tumor sample

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590 Ext. 88807; zhimin_shao@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: December 5, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)