Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

July 6, 2024 updated by: Rehab Osama Abdelmaboud, Assiut University

CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Data Record of the patients will be reviewed for the following:

Clinical features:

  • Age
  • Menopausal status
  • Family history
  • contraception
  • Comorbidities.

Pathological features:

  • Histological type of breast carcinoma
  • Grade
  • Lymphovascular invasion(LVI)
  • Ductal carcinoma insitu
  • TNM stage.
  • ER, PR, HER2 and Ki67.

Immunohistochemistry (IHC):

CD 10 expression by IHC staining

Type of Neoadjuvant CTH received:

  • AC (Adriamycin -cyclophosphamide)
  • taxans

Number of cycles

Response to neoadjuvant Chemotherapy:

Follow up :

Follow up of the patient during the course of treatment including evaluation of the patients by examination cycle by cycle till surgery to assess the adverse events and to evaluate the clinical response in addition to preoperative MRI or breast sonomamography.

Follow up after finishing the course of treatment by imaging and examination every 3 months for 2 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
groups: LABC patients who will receive neoadjuvant chemotherapy before surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
Overall survival (OS)
Time Frame: 2 years
the average length of time patients are alive after diagnosis or the start of treatment
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 6, 2024

First Submitted That Met QC Criteria

July 6, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 6, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • response to NAC in LABC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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