Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Pathological Complete Response (pCR)
Study Overview
Brief Summary
This study aims to investigate the correlation between immune-related factors in the tumor stroma and pathological complete response (pCR) in patients with early breast cancer treated with neoadjuvant chemotherapy. In addition, the study evaluates the association between immune-related tumor stroma factors and the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in peripheral blood. The study includes serial blood sampling before and after treatment and during follow-up to assess the prognostic value of these biomarkers for disease progression and recurrence.
Detailed Description
Neoadjuvant chemotherapy is widely used in patients with early breast cancer to reduce tumor size and improve surgical outcomes. Achieving a pathological complete response (pCR) is associated with improved prognosis; however, reliable predictive biomarkers are still limited. Recent evidence suggests that immune cells in the tumor microenvironment may influence treatment response.
This study evaluates immune-related tumor stroma factors (including tumor-infiltrating lymphocytes and immune marker profiles) in tumor tissue obtained prior to treatment. In parallel, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) are assessed from peripheral blood samples collected before neoadjuvant chemotherapy, after completion of treatment, and during follow-up.
The primary objective is to determine whether immune-related tumor stroma factors correlate with pCR after neoadjuvant chemotherapy. Secondary objectives include evaluating the association of immune-related factors with the presence of CTCs and ctDNA and assessing their prognostic value for disease progression and recurrence.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18 years or older.
- •Histologically confirmed early breast cancer.
- •Candidates for standard neoadjuvant chemotherapy.
- •Ability to provide informed consent.
Exclusion Criteria
- •Luminal A subtype of breast cancer.
- •Prior systemic therapy for breast cancer.
- •Serious comorbid conditions that would preclude study participation.
Arms & Interventions
Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy
Patients with early breast cancer receiving standard-of-care neoadjuvant chemotherapy according to institutional and international guidelines. Treatment is determined by the treating physician and is not assigned by the study protocol.
Intervention: Standard-of-Care Neoadjuvant Chemotherapy (Other)
Outcomes
Primary Outcomes
Pathological Complete Response (pCR)
Time Frame: At surgery following completion of neoadjuvant chemotherapy
Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Secondary Outcomes
No secondary outcomes reported