Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT02978495
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2016-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Carboplatin in Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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': 'D056831', 'term': 'Coordination Complexes'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.', 'timeFrame': 'within the first 21 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': 'within the first 60 month after surgery'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'within the first 60 month after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BRCA1 Hereditary Breast and Ovarian Cancer Syndrome']}, 'referencesModule': {'references': [{'pmid': '24794243', 'type': 'RESULT', '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': '24136883', 'type': 'RESULT', 'citation': 'Gerber B, Loibl S, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Nekljudova V, Untch M, von Minckwitz G; German Breast Group Investigators. Neoadjuvant bevacizumab and anthracycline-taxane-based chemotherapy in 678 triple-negative primary breast cancers; results from the geparquinto study (GBG 44). Ann Oncol. 2013 Dec;24(12):2978-84. doi: 10.1093/annonc/mdt361. Epub 2013 Oct 17.'}, {'pmid': '20008645', 'type': 'RESULT', 'citation': 'Byrski T, Gronwald J, Huzarski T, Grzybowska E, Budryk M, Stawicka M, Mierzwa T, Szwiec M, Wisniowski R, Siolek M, Dent R, Lubinski J, Narod S. Pathologic complete response rates in young women with BRCA1-positive breast cancers after neoadjuvant chemotherapy. J Clin Oncol. 2010 Jan 20;28(3):375-9. doi: 10.1200/JCO.2008.20.7019. Epub 2009 Dec 14.'}, {'pmid': '25092775', 'type': 'RESULT', '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': '26104428', 'type': 'RESULT', 'citation': 'Valsecchi ME, Kimmey G, Bir A, Silbermins D. Role of Carboplatin in the Treatment of Triple Negative Early- Stage Breast Cancer. Rev Recent Clin Trials. 2015;10(2):101-10. doi: 10.2174/1574887110666150624101343.'}, {'pmid': '21900106', 'type': 'RESULT', 'citation': 'Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C. Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-institution experience. J Clin Oncol. 2011 Oct 1;29(28):3739-46. doi: 10.1200/JCO.2011.35.2682. Epub 2011 Sep 6.'}, {'pmid': '21233401', 'type': 'RESULT', 'citation': 'Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res. 2011 Mar 1;17(5):1082-9. doi: 10.1158/1078-0432.CCR-10-2560. Epub 2011 Jan 13.'}, {'pmid': '27113739', 'type': 'RESULT', 'citation': 'Paluch-Shimon S, Friedman E, Berger R, Papa M, Dadiani M, Friedman N, Shabtai M, Zippel D, Gutman M, Golan T, Yosepovich A, Catane R, Modiano T, Kaufman B. Neo-adjuvant doxorubicin and cyclophosphamide followed by paclitaxel in triple-negative breast cancer among BRCA1 mutation carriers and non-carriers. Breast Cancer Res Treat. 2016 May;157(1):157-65. doi: 10.1007/s10549-016-3800-5. Epub 2016 Apr 25.'}, {'pmid': '25971625', 'type': 'RESULT', 'citation': 'Muendlein A, Rohde BH, Gasser K, Haid A, Rauch S, Kinz E, Drexel H, Hofmann W, Schindler V, Kapoor R, Decker T, Lang AH. Evaluation of BRCA1/2 mutational status among German and Austrian women with triple-negative breast cancer. J Cancer Res Clin Oncol. 2015 Nov;141(11):2005-12. doi: 10.1007/s00432-015-1986-2. Epub 2015 May 15.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Triple Negative Breast Cancer;\n* Stage II or III;\n* Performance Status ECOG \\<2 or Karnofsky \\>50%;\n* Hematologic (minimal values):\n\nAbsolute neutrophil count \\> 1,500/mm3 Hemoglobin \\> 10.0 g/dl Platelet count \\> 100,000/mm3\n\nExclusion Criteria:\n\n* Stage I or IV;\n* other malignancies.'}, 'identificationModule': {'nctId': 'NCT02978495', 'briefTitle': 'Neoadjuvant Carboplatin in Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Barretos Cancer Hospital'}, 'officialTitle': 'Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).', 'orgStudyIdInfo': {'id': 'BarretosCH - 20162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A- BRCA Mutation', 'description': '1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:\n2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: Cyclophosphamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B- BRCA Mutation', 'description': '1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:\n2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'C- BRCA wild-type', 'description': '1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:\n2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: Cyclophosphamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D- BRCA wild-type', 'description': '1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:\n2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorrubicin 60 mg/m2 4 cycles each 21 days', 'armGroupLabels': ['A- BRCA Mutation', 'B- BRCA Mutation', 'C- BRCA wild-type', 'D- BRCA wild-type']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin AUC 1,5 once a week, for 12 weeks', 'armGroupLabels': ['A- BRCA Mutation', 'C- BRCA wild-type']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '80mg/m2 weekly for 12 weeks', 'armGroupLabels': ['A- BRCA Mutation', 'B- BRCA Mutation', 'C- BRCA wild-type', 'D- BRCA wild-type']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '600mg/m2 4 cycles each 21 days', 'armGroupLabels': ['A- BRCA Mutation', 'B- BRCA Mutation', 'C- BRCA wild-type', 'D- BRCA wild-type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Barretos Cancer Hospital', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barretos Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cristiano de Padua', 'investigatorAffiliation': 'Barretos Cancer Hospital'}}}}