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NCT Number: NCT06499168

Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery

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.

Primary outcomes

  1. The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression

    Time frame: 6 months

Secondary outcomes

  1. progression free survival (PFS)

    Time frame: 2 years

    the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread

  2. Overall survival (OS)

    Time frame: 2 years

    the average length of time patients are alive after diagnosis or the start of treatment

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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