Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06718010

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Zhimin Shao, M.D.

CONTACT

[email protected]

+86-021-64175590 Ext. 88807

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Peripheral blood components related to efficacy

    Time frame: Approximately 18 months

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

Secondary outcomes

  1. Age-related components associated with efficacy

    Time frame: Approximately 18 months

    Identify age-related peripheral blood and tissue components associated with efficacy.

  2. Age-related peripheral blood components

    Time frame: Approximately 18 months

    Evaluate the differences in peripheral blood components between young and elderly patients.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhimin Shao, MD, PhD

CONTACT

[email protected]

+86-021-64175590 Ext. 88807

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.