Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Brief Title:
Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 HER2Neu 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-2neu 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
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 HER2Neu 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-2neu 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 HE 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
Histological diagnosis of HE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None