Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-29 @ 3:06 PM
Study NCT ID:
NCT01969032
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction Preoperative Chemotherapy for Patients With Locally Advanced 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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2013-10-21', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens', 'timeFrame': 'After 18 weeks os induction chemotherapy'}], 'primaryOutcomes': [{'measure': 'The pathological complete response rate to two consequent induction preoperative chemotherapy regimens', 'timeFrame': 'After 18 weeks of induction chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp', 'label': 'Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'Triple Negative Locally Advanced Breast Cancer, Induction Chemotherapy'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.', 'detailedDescription': "Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.\n\nOne of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients, age ≥18 years≤75\n* Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast\n* Stages Т2-4 N 2-3 M0\n* Signed inform consent\n\nExclusion Criteria:\n\n* Previous treatment for this breast cancer\n* History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease\n* Pregnancy or breast-feeding\n* Serious concurrent diseases or conditions that may alter chemotherapy conduction'}, 'identificationModule': {'nctId': 'NCT01969032', 'briefTitle': 'Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Russian Academy of Medical Sciences'}, 'officialTitle': 'Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'LATN-2ICR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 consequent anthracycline-taxane based chemotherapy regimens', 'description': 'Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks', 'interventionNames': ['Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine']}], 'interventions': [{'name': 'Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine', 'type': 'DRUG', 'description': 'Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks', 'armGroupLabels': ['2 consequent anthracycline-taxane based chemotherapy regimens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian Cancer Research Center named after N.N.Blokhin RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Associate of Department of Clinical Pharmacology and Chemotherapy', 'investigatorFullName': 'Mona Frolova', 'investigatorAffiliation': 'Russian Academy of Medical Sciences'}}}}