Characterizing breast stem and immune cells in early-stage breast cancer
Evaluation of Stem and Immune Cells in the Early Stage Breast Cancer Without Genetic Risk
This study looks at the breast stem and immune cells in women with early-stage breast cancer to see how they affect cancer growth and treatment, hoping to find new ways to help patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lyon) |
| Trial ID | NCT03870802 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult women with early-stage breast cancer, specifically those with Luminal A or Luminal B tumors. It aims to quantitatively and qualitatively characterize the breast stem cells and immune system cells present in the mammary gland after solitary confinement. The study will analyze the tumor micro-environment and its impact on cancer progression and treatment efficacy. By understanding the role of these cells, the research seeks to identify potential biomarkers for breast cancer risk and develop new therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older with early-stage breast cancer requiring total mastectomy, specifically those with Luminal A or Luminal B tumors.
Not a fit: Patients who have undergone prior anti-tumor treatments or those with chronic auto-immune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of breast cancer progression and inform new treatment strategies.
How similar studies have performed: While this approach is novel in its specific focus on breast stem and immune cells, similar studies have shown promise in understanding tumor micro-environments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patient requiring a breast surgery (total mastectomy) of an early stage tumour classified as : * Luminal A (Arm A) : Patients with a moderate risk of breast cancer progression or, * Luminal B or Basal (Arm B) : Patients with a high risk of breast cancer progression * Systemic treatment not initiated * Breast cup size ≥ C * Informed and signed consent. Exclusion Criteria: * Neo-adjuvant chemotherapy or hormonotherapy * History of breast irradiation * Pregnant or breastfeeding woman * Patient under tutorship or curatorship * Patient who underwent a lumpectomy with a level-2 oncoplastic surgery (ex: breast reduction with an inverted-T remodeling) * Any other prior anti-tumor treatment * Other medical pathology which may interfere with the biologic evaluation, especially chronic auto-immune diseases.
Where this trial is running
Lyon
- Centre Léon Bérard — Lyon, France (Recruiting)
Study contacts
- Principal investigator: DELAY Emmanuel, MD — Centre Leon Berard
- Study coordinator: DELAY Emmanuel, MD
- Email: emmanuel.delay@lyon.unicancer.fr
- Phone: +33 4.78.78.51.29
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.