Examining tumor-infiltrating lymphocytes in breast cancer patients after treatment
Do Tumor-Infiltrating Lymphocytes Predict Complete Pathologic Response to Neoadjuvant Systemic Therapy in Breast Cancer Patients?
This study looks at how certain immune cells in breast cancer tumors after treatment can help predict how well patients respond to therapy and their chances of staying cancer-free for a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | Trastuzumab, Pertuzumab, chemotherapy, immunotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05206396 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between tumor-infiltrating lymphocytes (TILs) and the pathologic complete response (pCR) in breast cancer patients who have undergone neoadjuvant systemic therapy. It focuses on patients with histologically confirmed invasive breast cancer, excluding those with early-stage or metastatic disease. The study aims to categorize TILs into three levels and assess their correlation with treatment outcomes and one-year invasive disease-free survival. The research utilizes pre-existing histopathological specimens for TIL assessment.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with histologically proven invasive breast cancer who have completed neoadjuvant systemic therapy.
Not a fit: Patients with early-stage T1N0 breast cancer, metastatic breast cancer, or those who did not complete their neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how TILs predict treatment responses, potentially leading to more personalized therapies for breast cancer patients.
How similar studies have performed: Previous studies have indicated that TILs can be predictive of treatment response in breast cancer, suggesting that this approach has been successful in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years old or more * Histologically proven invasive breast cancer * All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer * Patients who completed their systemic neoadjuvant therapy Exclusion Criteria: * Second malignancy * Patients who started but didn't complete neoadjuvant systemic therapy * Patients who didn't undergo surgery after neoadjuvant systemic therapy * Pregnant patients
Where this trial is running
Cairo
- Faculty of Medicine, Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Iman Sharawy, MD — Ain Shams University
- Study coordinator: Iman A Sharawy, MD
- Email: emanelsharawy@med.asu.edu.eg
- Phone: 01068280224
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.