Locally Advanced Breast CancerNCT06499168
Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
An observational study of Locally Advanced Breast Cancer, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients above 18 years
- Pathologically proven breast carcinoma
- Locally advanced breast cancer
Who cannot join
- Patients below 18 years.
- Patients with metastatic disease
- Patients with second primary cancer
- Patients ineligible for chemotherapy
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery
- Keywords
- response, neoadjuvant chemotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgeryDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| groups: LABC patients who will receive neoadjuvant chemotherapy before surgery. | Not described Receives: Drug: neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression
Measured: 6 months
Secondary outcomes (2)
progression free survival (PFS)
the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread
Measured: 2 years
Overall survival (OS)
the average length of time patients are alive after diagnosis or the start of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Osama Abdelmaboud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499168
- Sponsor's protocol ID
- response to NAC in LABC
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06499168
- Acronym / sponsor ID
- response to NAC in LABC
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- response, neoadjuvant chemotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| groups: LABC patients who will receive neoadjuvant chemotherapy before surgery. | – | Drug: neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients above 18 years
- Pathologically proven breast carcinoma
- Locally advanced breast cancer
Key exclusion criteria (4 listed)
- Patients below 18 years.
- Patients with metastatic disease
- Patients with second primary cancer
- Patients ineligible for chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgeryIn 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. | Drug | groups: LABC patients who will receive neoadjuvant chemotherapy before surgery. |
Primary outcome
The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression
Time frame: 6 months
2 secondary outcomes
progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.