NCT06499168

Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Female breast cancer is the second leading cause of global cancer incidence in 2022 and the fourth leading cause of cancer mortality worldwide. Breast cancer (BC) remains the most prevalent cancer diagnosis among women; nevertheless, considerable advancements in diagnostics and treatment approaches have significantly enhanced patient outcomes. In locally advanced cases, primary systemic chemotherapy is often indicated, and the choice of treatment is influenced by the evaluation of routine prognostic and predictive factors. Neoadjuvant chemotherapy (NCT) has emerged as a valuable approach to enhance the quality of life ,disease-free and overall survival for early and locally advanced BC patients Approximately 30% of BC cases achieve a pathological complete response (pCR) following NCT. Unfortunately, proper quantification of estrogen- and progesterone receptors (ER and PR), human epidermal growth factor receptor-2 (HER2/Neu) and proliferation markers are insufficient to predict chemosensitivity of some breast tumors , so the identification of these cases during routine pathological examination of biopsy specimens could be especially useful in planning the oncotherapeutic strategy for proper patient management. CD10, has recently gained attention as an independent diagnostic and prognostic marker in various solid tumors with significant metastatic potential. This molecule has been shown to play a role in cell adhesion, migration, and extracellular matrix remodelling. A strong CD10 expression has been linked to hormone receptor negativity and HER-2/neu overexpression in breast cancer. Moreover, the dynamics of stromal CD10 expression undergo changes during neoadjuvant anthracycline-based chemotherapy. Recent research, has presented compelling data indicating that CD10 expression may serve as a predictive marker for the impact of neoadjuvant chemotherapy in breast cancer patients.

Detailed description

Formalin fixed paraffin embedded tissue specimen of the baseline TCNB of locally advanced breast cancer will be obtained from pathology laboratory, Pathology Department, Assiut University. * Histological diagnosis of H\&E stained sections will be confirmed. * Immunohistochemical staining for CD10 . * Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records. * Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy.

Conditions

• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery	In locally advanced breast cancer patients who will receive neoadjuvant chemotherapy formalin fixed paraffin embedded tissue specimen of the baseline TCNB of locally advanced breast cancer will be obtained from pathology laboratory, Pathology Department, Assiut University. * Histological diagnosis of H\&E stained sections will be confirmed. * Immunohistochemical staining for CD10 . * Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records. * Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2027-08-01
• First posted: 2024-07-12
• Last updated: 2024-07-12

Regulatory

• FDA-regulated drug study