Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06965361
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2025-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stromal Tumor-Infiltrating Lymphocyte Levels Are Associated With Immune Checkpoint Proteins In Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stromal tumor-infiltrating lymphocyte levels are associated with immune checkpoint proteins in triple negative breast cancer patients receiving neoadjuvant chemotherapy', 'timeFrame': 'From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days.', 'description': 'The TILs levels were evaluated on Hematoxylin-eosin-stained (H\\&E) tissue sections as percentages and three predefined categories were used: Low TIL scores of 0-10%, intermediate 11-40% and high TIL \\> 40%.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of PD-1, PD-L1 and LAG-3 in triple negative breast cancer patients receiving neoadjuvant chemotherapy', 'timeFrame': 'From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days.', 'description': "Patients (n=54; aged;24-45 years) were classified into two groups: thirty-nine received anthracycline-containing, taxane- (A+T group) and fifteen received anthracycline/taxane /carboplatin (A+T+C group) in combinations. Immunohistochemistry (IHC) staining was used for the evaluation of PD-1, PD-L1 and LAG-3. However, TIL assessment was done by hematoxylin and eosin (H\\&E)-staining in TNBC patient's biopsies who received NACT."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['carboplatin-based NACT regimen', 'tumor-infiltrating lymphocytes', 'Programmed cell death-1', 'Programmed cell death Ligand-1', 'lymphocyte activation gene-3', 'Triple-negative breast cancer'], 'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30335131', 'type': 'BACKGROUND', 'citation': 'Loibl S, Weber KE, Timms KM, Elkin EP, Hahnen E, Fasching PA, Lederer B, Denkert C, Schneeweiss A, Braun S, Salat CT, Rezai M, Blohmer JU, Zahm DM, Jackisch C, Gerber B, Klare P, Kummel S, Schem C, Paepke S, Schmutzler R, Rhiem K, Penn S, Reid J, Nekljudova V, Hartman AR, von Minckwitz G, Untch M. Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response-final results from GeparSixto. Ann Oncol. 2018 Dec 1;29(12):2341-2347. doi: 10.1093/annonc/mdy460.'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC6369970/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the effects of neoadjuvant chemotherapy (NACT) anthracycline-containing, taxane- (Intervention A +T) and anthracycline/taxane /carboplatin (Intervention A+T+C) treatment in young (age; 24-45 years) Triple Negative Breast Cancer (TNBC) female Patients by evaluating Stromal tumor-infiltrating lymphocytes (TILs) Programmed cell death-1 (PD-1), its ligand (PD-L1) and lymphocyte activation gene-3 (LAG-3) checkpoint proteins within tumor.\n\nThe main question it aims to answer is:\n\nDoes TILs are the most reliable immune markers and are significantly associated with PD-1, PD-L1 and LAG-3 in carboplatin based NACT treated (Intervention A+T+C) group of TNBC patients? Participants (TNBC Patients) already taking intervention A+T and A+T+C as part of their regular medical care for TNBC.', 'detailedDescription': "Stromal tumor-infiltrating lymphocytes (TILs) are currently being considered as a prognostic factor in triple-negative breast cancer (TNBC) and their association with the tumor immune microenvironment is less clear. To address this knowledge gap, investigators aimed to evaluate the expression and association of Programmed cell death-1 (PD-1), its ligand (PD-L1) and lymphocyte activation gene-3 (LAG-3) checkpoint proteins with TILs in neoadjuvant chemotherapy (NACT) treated TNBC patients.\n\nPatients (n=54; aged;24-45 years) were classified into two groups: thirty-nine received anthracycline-containing, taxane- (A+T group) and fifteen received anthracycline/taxane /carboplatin (A+T+C group) in combinations. Immunohistochemistry (IHC) staining was used for the evaluation of PD-1, PD-L1 and LAG-3. However, TIL assessment was done by hematoxylin and eosin (H\\&E)-staining in TNBC patient's biopsies who received NACT."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '24 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Karachi subset of population', 'genderDescription': 'Women with diagnosed TNBC (Age;24-45 years)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female (aged 24-45 years) TNBC patients\n* Diagnosed TNBC Patients with immunohistochemistry (IHC) negative test for estrogen receptor (ER), progesterone receptor (PR), and HER-2\n* Patients with and without metastases\n\nExclusion Criteria:\n\n* Patients who had a history of other malignant tumors\n* Patients who did not complete NAC.'}, 'identificationModule': {'nctId': 'NCT06965361', 'acronym': 'TIL; PD1; PDL1', 'briefTitle': 'Stromal Tumor-Infiltrating Lymphocyte Levels Are Associated With Immune Checkpoint Proteins In Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Stromal Tumor-Infiltrating Lymphocyte Levels Are Associated With Immune Checkpoint Proteins In Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': '1730120SMBIO'}, 'secondaryIdInfos': [{'id': '20-11952/NRPU/RGM/R&D/HEC', 'type': 'OTHER_GRANT', 'domain': 'Higher Education Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A+T group and A+T+C group', 'description': 'All TNBC patients included in the study received at least four cycles of NACT regimens and were classified into two groups: anthracycline-containing, taxane- (A+T group) and anthracycline/taxane/carboplatin (A+T+C group) combinations', 'interventionNames': ['Drug: carboplatin', 'Device: carboplatin']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Doxorubicin'], 'description': 'carboplatin use due to its effectiveness in increasing pathological complete remission (pCR) rates and improving survival outcomes', 'armGroupLabels': ['A+T group and A+T+C group']}, {'name': 'carboplatin', 'type': 'DEVICE', 'otherNames': ['Carpsol®'], 'description': 'used in the treatment of triple-negative breast cancer (TNBC) due to its effectiveness in achieving pathological complete response (pCR) and breast-conserving surgery (BCS) rates.', 'armGroupLabels': ['A+T group and A+T+C group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75270', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Shamim', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Shamim Mushtaq, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinnah Sindh Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shamim Mushtaq', 'investigatorAffiliation': 'Ziauddin University'}}}}