Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT05872412
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double-blinded randomized controlled trial to explore the efficacy and toxicity of platinum-based versus non-platinum-based neoadjuvant chemotherapy in triple-negative breast cancer.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-05-14', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response rate', 'timeFrame': '1 year', 'description': 'Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes.'}], 'secondaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': '1 year', 'description': 'Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which rely on a history, clinical exam, and imaging.'}, {'measure': 'Treatment related acute toxicity', 'timeFrame': '1 year', 'description': 'The American National Cancer Institute\'s "Common Terminology Criteria for Adverse Events" will be utilized to assess toxicity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple negative breast cancer', 'Platinum', 'Neoadjuvant'], 'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24794243', 'type': 'BACKGROUND', 'citation': 'von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.'}, {'pmid': '27447966', 'type': 'BACKGROUND', 'citation': 'Zhang P, Yin Y, Mo H, Zhang B, Wang X, Li Q, Yuan P, Wang J, Zheng S, Cai R, Ma F, Fan Y, Xu B. Better pathologic complete response and relapse-free survival after carboplatin plus paclitaxel compared with epirubicin plus paclitaxel as neoadjuvant chemotherapy for locally advanced triple-negative breast cancer: a randomized phase 2 trial. Oncotarget. 2016 Sep 13;7(37):60647-60656. doi: 10.18632/oncotarget.10607.'}, {'pmid': '25092775', 'type': 'BACKGROUND', 'citation': 'Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.'}, {'pmid': '26341644', 'type': 'BACKGROUND', 'citation': 'Kumar P, Aggarwal R. An overview of triple-negative breast cancer. Arch Gynecol Obstet. 2016 Feb;293(2):247-69. doi: 10.1007/s00404-015-3859-y. Epub 2015 Sep 4.'}, {'pmid': '17671126', 'type': 'BACKGROUND', 'citation': 'Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.'}, {'pmid': '28494179', 'type': 'BACKGROUND', 'citation': 'Jin J, Zhang W, Ji W, Yang F, Guan X. Predictive biomarkers for triple negative breast cancer treated with platinum-based chemotherapy. Cancer Biol Ther. 2017 Jun 3;18(6):369-378. doi: 10.1080/15384047.2017.1323582. Epub 2017 May 11.'}, {'pmid': '23558900', 'type': 'BACKGROUND', 'citation': 'Lips EH, Mulder L, Oonk A, van der Kolk LE, Hogervorst FB, Imholz AL, Wesseling J, Rodenhuis S, Nederlof PM. Triple-negative breast cancer: BRCAness and concordance of clinical features with BRCA1-mutation carriers. Br J Cancer. 2013 May 28;108(10):2172-7. doi: 10.1038/bjc.2013.144. Epub 2013 Apr 4.'}, {'pmid': '25048467', 'type': 'BACKGROUND', 'citation': 'Prat A, Cruz C, Hoadley KA, Diez O, Perou CM, Balmana J. Molecular features of the basal-like breast cancer subtype based on BRCA1 mutation status. Breast Cancer Res Treat. 2014 Aug;147(1):185-91. doi: 10.1007/s10549-014-3056-x. Epub 2014 Jul 22.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '29275435', 'type': 'BACKGROUND', 'citation': 'Telli ML, Hellyer J, Audeh W, Jensen KC, Bose S, Timms KM, Gutin A, Abkevich V, Peterson RN, Neff C, Hughes E, Sangale Z, Jones J, Hartman AR, Chang PJ, Vinayak S, Wenstrup R, Ford JM. Homologous recombination deficiency (HRD) status predicts response to standard neoadjuvant chemotherapy in patients with triple-negative or BRCA1/2 mutation-associated breast cancer. Breast Cancer Res Treat. 2018 Apr;168(3):625-630. doi: 10.1007/s10549-017-4624-7. Epub 2017 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.', 'detailedDescription': 'Breast cancer is a significant health concern, and triple-negative breast cancer (TNBC) is a particularly aggressive and lethal subtype. Chemotherapy is currently the only recommended systemic treatment for TNBC, with the standard regimen being a combination of anthracyclines and taxanes. Platinum agents have shown promising results in TNBC neoadjuvant chemotherapy due to their ability to damage DNA and be more effective in tumors with dysfunctional DNA repair mechanisms. However, there is still a lack of consensus on the optimal neoadjuvant chemotherapy regimen for TNBC. This study will be conducted to compare the responses and toxicities of platinum-based versus non-platinum-based neoadjuvant chemotherapy in TNBC patients receiving neoadjuvant chemotherapy in the Department of Clinical Oncology of Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka. After pretreatment evaluation, a total of 82 patients who fulfill the inclusion and exclusion criteria will be divided into Arm A and Arm B by simple random sampling. After the completion of the chemotherapy, all patients will undergo surgical management. A postoperative histopathology report will be collected and assessed by the investigator. During the treatment, the patients will be monitored before each cycle of chemotherapy, including physical examinations and laboratory investigations. All the relevant data will be compiled on a master chart first, and then statistical analysis of the results will be obtained by using Windows-based computer software facilities with Statistical Packages for Social Sciences. The data will be analyzed using the Chi-square test and the "T\' test. The results will be presented in tables, figures, and diagrams. A significant value of \'p\' will be decided at a level of 0.05 in two-tailed tests.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Triple-negative breast cancer\n* Stage II and III\n\nExclusion Criteria:\n\n* Double primaries\n* Male breast cancer\n* Pregnant or lactating women\n* Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than two\n* Patients below 18 years old\n* Initial surgery of the primary site (excluding diagnostic biopsy)\n* Serious concomitant medical illness including clinically significant cardiovascular disease\n* Major surgery or trauma in the previous four weeks'}, 'identificationModule': {'nctId': 'NCT05872412', 'briefTitle': 'Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer', 'orgStudyIdInfo': {'id': 'BSMMU/2023/6669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platinum-based regimen', 'description': 'Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks concurrently with carboplatin (area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles).', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-platinum based regimen', 'description': 'Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['Adriamycin'], 'description': '60 mg/m2 IV bolus on day 1 every three weeks for four cycles.', 'armGroupLabels': ['Non-platinum based regimen', 'Platinum-based regimen']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': '600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.', 'armGroupLabels': ['Non-platinum based regimen', 'Platinum-based regimen']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '80 mg/m2 IV over 1 hour weekly for 12 weeks', 'armGroupLabels': ['Non-platinum based regimen', 'Platinum-based regimen']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles', 'armGroupLabels': ['Platinum-based regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Sajib K Talukdhar, MBBS, MD', 'role': 'CONTACT', 'email': 'sajibkumar@bsmmu.edu.bd', 'phone': '+8801723620231'}, {'name': 'Mohammad J Shams, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sajib K Talukdhar, MBBS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Mohammad J Shams, MBBS, MD', 'role': 'CONTACT', 'email': 'jsnitol@gmail.com', 'phone': '+8801911177774'}, {'name': 'Sajib K Talukdhar, MBBS, MD', 'role': 'CONTACT', 'email': 'sajibkumar@bsmmu.edu.bd', 'phone': '+8801723620231'}], 'overallOfficials': [{'name': 'Mohammad J Shams, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Officer, Department of Clinical Oncology', 'investigatorFullName': 'Mohammad Jahan Shams', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}