Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 2:27 AM
Study NCT ID:
NCT01199393
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'about 4ml peripheral vein blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to chemotherapy', 'timeFrame': '6 months', 'description': 'Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression', 'timeFrame': '1 year', 'description': 'Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.'}, {'measure': 'Toxicity', 'timeFrame': '6 months', 'description': 'Toxicity, as a measure of safety and tolerability, is assessed by the percent of participants with adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC). Possible toxicities include neutropenia, anemia, thrombocytopenia, nausea and vomitting, allergy, and so on.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast neoplasm', 'drug therapy', 'polymorphism', 'gene'], 'conditions': ['Breast Neoplasm', 'Drug Therapy', 'Polymorphism,Single Nucleotide']}, 'descriptionModule': {'briefSummary': 'The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.', 'detailedDescription': '1. Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.\n2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.\n3. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female patients with metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic breast cancer\n* Female\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* At least one measurable lesion\n* Normal cardiac, hepatic, renal and bone marrow functions\n* Life expectancy ≥3 months\n* Discontinuity of previous chemotherapy for a minimum of 4 weeks\n\nExclusion Criteria:\n\n* Central nervous system metastases\n* Serious or uncontrolled concurrent medical illness\n* History of other malignancies'}, 'identificationModule': {'nctId': 'NCT01199393', 'briefTitle': 'Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'snp'}}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ningning Dong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}, {'name': 'Jun Jia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jun Ren', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}