Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 6:08 AM
Study NCT ID:
NCT00870168
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for 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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in hormone receptor expression'}]}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'estrogen receptor-negative breast cancer', 'progesterone receptor-negative breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.\n\nSecondary\n\n* Assess changes in HER1 and HER2 expression during treatment.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.\n\nPatients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.\n\nAfter completion of study treatment, patients are followed every 6 months for 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the breast\n\n * Metastatic disease\n* No inflammatory breast cancer\n* Measurable disease according to RECIST criteria\n* Hormone receptor status:\n\n * Estrogen receptor- and/or progesterone receptor-negative by IHC\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* WHO performance status 0-2\n* Life expectancy \\> 3 months\n* ANC \\> 1.5 x 10\\^9/L\n* Platelet count \\> 100 x 10\\^9/L\n* Liver transaminases ≤ 3 times upper limit of normal (ULN)\n* Alkaline phosphatase ≤ 3 times ULN\n* Bilirubin ≤ 1.5 times ULN\n* Creatinine ≤ 2 times ULN\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No allergy to xylocaine\n* No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior first-line treatment for metastatic disease'}, 'identificationModule': {'nctId': 'NCT00870168', 'briefTitle': 'Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.', 'orgStudyIdInfo': {'id': 'CDR0000626717'}, 'secondaryIdInfos': [{'id': 'JEANP-AU-613'}, {'id': 'INCA-RECF0389'}, {'id': 'JEANP-RH Meta Sein'}, {'id': 'PFIZER-JEANP-AU-613'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chemotherapy', 'type': 'DRUG'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'breast biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Philippe Chollet, MD, PhD', 'affiliation': 'Centre Jean Perrin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}}}}