Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-25 @ 7:58 AM
Study NCT ID:
NCT06499168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', '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.\n\n* Histological diagnosis of H\\&E stained sections will be confirmed.\n* Immunohistochemical staining for CD10 .\n* Baseline clinicopathological features of patients who received neoadjuvant chemotherapy will be collected from patients' records.\n* Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-06', 'studyFirstSubmitDate': '2024-07-06', 'studyFirstSubmitQcDate': '2024-07-06', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'progression free survival (PFS)', 'timeFrame': '2 years', 'description': 'the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'the average length of time patients are alive after diagnosis or the start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['response, neoadjuvant chemotherapy, breast cancer'], 'conditions': ['Locally Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nNeoadjuvant 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.\n\nCD10, 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.\n\nA 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.\n\nRecent 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.', 'detailedDescription': "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.\n\n* Histological diagnosis of H\\&E stained sections will be confirmed.\n* Immunohistochemical staining for CD10 .\n* Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records.\n* Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Data Record of the patients will be reviewed for the following:\n\nClinical features:\n\n* Age\n* Menopausal status\n* Family history\n* contraception\n* Comorbidities.\n\nPathological features:\n\n* Histological type of breast carcinoma\n* Grade\n* Lymphovascular invasion(LVI)\n* Ductal carcinoma insitu\n* TNM stage.\n* ER, PR, HER2 and Ki67.\n\nImmunohistochemistry (IHC):\n\nCD 10 expression by IHC staining\n\nType of Neoadjuvant CTH received:\n\n* AC (Adriamycin -cyclophosphamide)\n* taxans\n\nNumber of cycles\n\nResponse to neoadjuvant Chemotherapy:\n\nFollow up :\n\nFollow 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.\n\nFollow up after finishing the course of treatment by imaging and examination every 3 months for 2 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years\n* Pathologically proven breast carcinoma\n* Locally advanced breast cancer\n\nExclusion Criteria:\n\n* Patients below 18 years.\n* Patients with metastatic disease\n* Patients with second primary cancer\n* Patients ineligible for chemotherapy'}, 'identificationModule': {'nctId': 'NCT06499168', 'briefTitle': 'Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'response to NAC in LABC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'groups: LABC patients who will receive neoadjuvant chemotherapy before surgery.', 'interventionNames': ['Drug: neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery']}], 'interventions': [{'name': 'neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery', 'type': 'DRUG', 'description': "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.\n\n* Histological diagnosis of H\\&E stained sections will be confirmed.\n* Immunohistochemical staining for CD10 .\n* Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records.\n* Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy.", 'armGroupLabels': ['groups: LABC patients who will receive neoadjuvant chemotherapy before surgery.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Rehab Osama Abdelmaboud', 'investigatorAffiliation': 'Assiut University'}}}}