Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT00471159
Status:
WITHDRAWN
Last Update Posted:
2015-05-04
First Post:
2007-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced 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'}, {'id': 'C483020', 'term': 'ProMune'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-30', 'studyFirstSubmitDate': '2007-05-07', 'studyFirstSubmitQcDate': '2007-05-07', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Tumor assessment every 6 weeks until disease progression'}], 'secondaryOutcomes': [{'measure': 'Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression'}, {'measure': 'Overall Survival - Patients will be followed for survival'}, {'measure': 'Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up'}, {'measure': 'Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy'}]}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8501007&StudyName=A%20Study%20Of%20Docetaxel%20Or%20Docetaxel%20Plus%20PF-3512676%20To%20Treat%20Patients%20With%20Advanced%20Breast%20Cancer.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with confirmed advanced breast cancer.\n* Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.\n* Patients with adequate general well-being, kidney and liver function.\n\nExclusion Criteria:\n\n* Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.\n* Patients who have had prior chemotherapy for advanced breast cancer.\n* Patients of child-bearing potential who are unwilling to use contraception.'}, 'identificationModule': {'nctId': 'NCT00471159', 'briefTitle': 'A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'A8501007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'PF-3512676', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}