Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT01352494
Status:
UNKNOWN
Last Update Posted:
2011-05-27
First Post:
2011-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-08-02', 'releaseDate': '2017-10-31'}], 'estimatedResultsFirstSubmitDate': '2017-10-31'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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': 'D006571', 'term': 'Heterocyclic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-25', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2011-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate was assessed by pathologic examination after surgery.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Type of surgery (Breast Conserving Rate)', 'timeFrame': '6 month'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '1 year'}, {'measure': 'progression free survival', 'timeFrame': '2 years'}, {'measure': 'quality of life', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['locally advanced breast cancer', 'docetaxel', 'gemcitabine'], 'conditions': ['Breast Cancer Stage II', 'Breast Cancer Stage III']}, 'referencesModule': {'references': [{'pmid': '29285038', 'type': 'DERIVED', 'citation': 'Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.', 'detailedDescription': 'Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged : 20\\~70 years\n2. World Health Organization (WHO) (Eastern Cooperative Oncology Group \\[ECOG\\]) performance status 0-2\n3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline\n4. Have given written informed consent and are available for prolonged follow-up\n\nExclusion Criteria:\n\n1. Patients with previous chemotherapy for recurrent breast cancer\n2. Breast cancer recurrence within 12 months after taxane treatment\n3. Her-2/neu expression breast cancer\n4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.\n5. Brain metastasis\n6. uncontrolled infection, medically uncontrollable heart disease\n7. other serious medical illness or prior malignancies\n8. Pregnant or lactating women were excluded.'}, 'identificationModule': {'nctId': 'NCT01352494', 'acronym': 'NeoTG', 'briefTitle': 'Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Korean Breast Cancer Study Group'}, 'officialTitle': 'A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'KBCSG009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'docetaxel/gemcitabine', 'description': 'All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)', 'interventionNames': ['Drug: docetaxel', 'Drug: gemcitabine']}], 'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'otherNames': ['Doxotel®'], 'description': 'docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles', 'armGroupLabels': ['docetaxel/gemcitabine']}, {'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcibine®'], 'description': 'gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles', 'armGroupLabels': ['docetaxel/gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Young Jin Suh, M.D. Ph.D', 'role': 'CONTACT', 'email': 'youngjin.suh@gmail.com', 'phone': '82-31-249-7114'}], 'facility': "Department of Surgery, the Catholic university of Korea, St. Vincent's hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Ku Sang Kim, M.D.', 'role': 'CONTACT', 'email': 'ideakims@gmail.com', 'phone': '82-31-219-5200'}], 'overallOfficials': [{'name': 'Young Jin Suh, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Surgery, the Catholic university of Korea, St. Vincent's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Breast Cancer Study Group', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Young Jin Suh', 'oldOrganization': "Department of Surgery, the Catholic university of Korea, St. Vincent's hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-31', 'type': 'RELEASE'}, {'date': '2018-08-02', 'type': 'RESET'}], 'unpostedResponsibleParty': "Ku Sang Kim, Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korean Breast Cancer Study Group"}}}}