Examining blood components in young and elderly breast cancer patients
Age-Related Peripheral Blood Components and Their Association With Treatment Efficacy in Breast Cancer Patients: An Observational Cohort Study
This study looks at the blood of young and older women with a specific type of breast cancer to see if certain blood components can help predict how well younger patients will do during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06718010 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare peripheral blood components between young and elderly patients with HR+HER2- breast cancer undergoing neoadjuvant therapy. It will analyze both retrospective data from existing medical records and prospective data collected during routine clinical treatment. The goal is to identify blood components that may influence the prognosis of younger patients with this specific type of breast cancer. The study will continue until patients complete their neoadjuvant therapy and undergo surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 years or older with histologically confirmed HR+HER2- breast cancer requiring neoadjuvant therapy.
Not a fit: Patients with distant metastasis or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor treatment strategies for young HR+HER2- breast cancer patients based on their blood component profiles.
How similar studies have performed: While similar studies have explored blood components in cancer prognosis, this specific focus on age-related differences in HR+HER2- breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center Shanghai, China, 200032 — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhimin Shao, MD, PhD
- Email: zhimin_shao@yeah.net
- Phone: +86-021-64175590 Ext. 88807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.