Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT02041351
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2014-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biweekly Docetaxel 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2014-01-18', 'studyFirstSubmitQcDate': '2014-01-18', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free interval', 'timeFrame': '4 months', 'description': 'more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed'}], 'secondaryOutcomes': [{'measure': 'partial response', 'timeFrame': '2 months', 'description': 'Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.'}, {'measure': 'rate response', 'timeFrame': '3 months', 'description': 'percentage of patients who responded with a decrease greater than 40% of the lesions at the time of initiation of this treatment after 3 months of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metastatic breast cancer', 'taxanes', 'heavily pretreated'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.', 'detailedDescription': 'Methodology:\n\nProspective non-randomized phase IIa. The selected patients with metastatic breast cancer heavily pretreated including those previously treated with taxanes, receive docetaxel administered at a dose of 45mg/m2 body surface every 2 weeks to assess the activity of this drug.\n\nVariables:\n\nAge. Menopausal status. Hormone receptor status. Overexpression of HER2 neu. Location of metastatic sites. Performance status (PS) 0-3. comorbidities.\n\nCase management in the variables (patient subgroups )\n\nThe patients with HER 2 neu overexpression of anti -HER2 therapy will further chemotherapy with docetaxel.\n\nThe patients presenting with brain metastases may receive radiation therapy to the brain and then at the end of radiotherapy, start docetaxel.\n\nPatients whose tumors express estrogen receptors and progesterone positive receive treatment with docetaxel:\n\nWhere there is visceral crisis and it is shown that they have already progressed to more than 2 lines of previously administered hormone treatment.\n\nIn no event cytotoxic chemotherapy with concurrent docetaxel was administered to an anti-estrogen drug.\n\nAnd they can continue only when hormone therapy has achieved complete response measurable lesions with docetaxel and opt for a non-cytotoxic anti-estrogen therapy and when it came to presenting unacceptable toxicity with docetaxel.\n\nEvaluations:\n\nclinical assessment that will include physical examination and review of laboratory studies were carried out every 2 weeks before authorizing the housing management of a next cycle.\n\nThe objective assessment of tumor response was carried out by imaging studies (CT) by RECIST criteria after administration of the 4 criteria of cycles, a cycle is administered every 2 weeks with docetaxel at a dose of 45mg/m2.\n\nResponse Criteria\n\n1. Response tumor shrinkage by royalty over 30%.\n2. Greater than 1 cm in the size of tumor lesions decrease.\n3. Disease-free survival\n4. Progression-free survival.\n5. Stable disease\n6. Improved quality of life that is decreased bone pain, improvement of dyspnea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Women over 21 years of age diagnosed with breast cancer in clinical stage IV, who had received 3 or more lines of cytotoxic chemotherapy, which may have included paclitaxel or docetaxel, which have measurable or evaluable tumor activity in any distant organ and who are fully conscious and well oriented to permit informed consent.\n\nExclusion Criteria:\n\nMale patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and over 85 years of age. Metastasis of one site in the central nervous system.'}, 'identificationModule': {'nctId': 'NCT02041351', 'briefTitle': 'Biweekly Docetaxel in Patients With Metastatic Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario contra el Cáncer'}, 'officialTitle': 'Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.', 'orgStudyIdInfo': {'id': 'ON13-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'docetaxel', 'description': 'measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['evaluating the response rate and progression-free interval'], 'description': 'evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy', 'armGroupLabels': ['docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Centro Universitario Contra El Cáncer', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Jesus Livio Jimenez Santos', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Jesús L Santos, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Universitario contra el Cáncer U.A.N.L.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario contra el Cáncer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical oncology resident', 'investigatorFullName': 'Jesus Livio Jimenez Santos', 'investigatorAffiliation': 'Centro Universitario contra el Cáncer'}}}}