Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

NCT ID: NCT06499168

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-08-31

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 (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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

groups: LABC patients who will receive neoadjuvant chemotherapy before surgery.

neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients above 18 years
• Pathologically proven breast carcinoma
• Locally advanced breast cancer

Exclusion Criteria

• Patients below 18 years.
• Patients with metastatic disease
• Patients with second primary cancer
• Patients ineligible for chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Osama Abdelmaboud

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

response to NAC in LABC

Identifier Type: -

Identifier Source: org_study_id