{ "FullStudy":{ "Rank":217962, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514565", "OrgStudyIdInfo":{ "OrgStudyId":"11D-574" }, "Organization":{ "OrgFullName":"Thomas Jefferson University", "OrgClass":"OTHER" }, "BriefTitle":"Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer", "OfficialTitle":"Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer." }, "StatusModule":{ "StatusVerifiedDate":"March 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2015", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2018", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 17, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 18, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Thomas Jefferson University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is a prospective observational study aimed to validate biomarkers that predict response.", "DetailedDescription":"This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Triple negative Breast Cancer", "RB", "PTEN", "Chemotherapy", "Neoadjuvant" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"70", "EnrollmentType":"Anticipated" } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Histological status of retinoblastoma tumour suppressor (RB)", "PrimaryOutcomeDescription":"The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.", "PrimaryOutcomeTimeFrame":"Nine weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Correlation of RB and other biomarkers", "SecondaryOutcomeDescription":"Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR\nCorrelation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)", "SecondaryOutcomeTimeFrame":"Nine weeks" },{ "SecondaryOutcomeMeasure":"Determine the utility of an RB molecular test", "SecondaryOutcomeDescription":"Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.", "SecondaryOutcomeTimeFrame":"Assessed within 1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge > 18 years old\nHistologically-confirmed triple negative invasive breast carcinoma\nAny type of ductal or lobular invasive carcinoma\nPatients with or without BRCA-1 and BRCA-2 mutations are eligible to participate\nLife expectancy > 6 months\nPre-, Peri- or Postmenopausal\nClinical Stage T2-4, N0-3, M0 (Stage II-III)\nPatients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial\nAdequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. However, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.\n\nExclusion Criteria:\n\nPrior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)\nPatients with a \"currently active\" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).\nOnly ductal/lobular carcinoma in situ but not invasive component\nAny sort of confirmed metastatic disease (AJCC Stage IV at diagnosis)\nAny sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy\nPregnant or lactating, in case this precludes the subject to receive chemotherapy.\nImpossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. This will be exclusively decided by the treating oncologists.", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"A maximum of 70 eligible patients will be enrolled. Accrual is expected to be completed in 18-24 months. All patients must have histologically confirmed triple negative breast cancer and be eligible to receive neoadjuvant chemotherapy.", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Agnieszka Witkiewicz, MD", "CentralContactRole":"Contact", "CentralContactPhone":"215-955-3778", "CentralContactEMail":"Agnieszka.Witkiewicz@jefferson.edu" },{ "CentralContactName":"Gordon Schwartz, MD", "CentralContactRole":"Contact", "CentralContactPhone":"215-955-6999", "CentralContactEMail":"Gordon.Schwartz@jefferson.edu" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Agnieszka Witkiewicz, MD", "OverallOfficialAffiliation":"Thomas Jefferson University", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Gordon Schwartz, MD", "OverallOfficialAffiliation":"Thomas Jefferson University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Thomas Jefferson University", "LocationStatus":"Recruiting", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19107", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Agnieszka Witkiewicz, MD", "LocationContactRole":"Contact", "LocationContactPhone":"215-955-3778", "LocationContactEMail":"Agnieszka.Witkiewicz@jefferson.edu" },{ "LocationContactName":"Gordon Schwartz, MD", "LocationContactRole":"Contact", "LocationContactPhone":"215-955-6999", "LocationContactEMail":"Gordon.Schwartz@jefferson.edu" },{ "LocationContactName":"Matias Valsecchi, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"A. Kathleen McClendon, PhD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Adam Berger, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Sunny Lee, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Barbara Cavanaugh, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Frederick Fellin, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Allison Zibelli, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Tiffany Avery, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Rebecca Jaslow, MD", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Erik Knudsen, PhD", "LocationContactRole":"Sub-Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001943", "ConditionMeshTerm":"Breast Neoplasms" },{ "ConditionMeshId":"D000064726", "ConditionMeshTerm":"Triple Negative Breast Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000001941", "ConditionAncestorTerm":"Breast Diseases" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafAsFound":"Breast Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M28960", "ConditionBrowseLeafName":"Triple Negative Breast Neoplasms", "ConditionBrowseLeafAsFound":"Triple Negative Breast Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3800", "ConditionBrowseLeafName":"Breast Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }