[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575572":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":84,"collaborators":86,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":10,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: HR+\u002FHER2- mBC participants enrolled before first line ADC (ADC1))",null,"Participants with histologically documented HR+\u002FHER2- MBC with a plan to start an FDA-approved ADC as a first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.",[13,14,15],"Procedure: Specimen collection","Drug: Non-Investigational Antibody-Drug Conjugates (ADC)","Other: Medical Record Review",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1","Participants with histologically documented metastatic TNBC with a plan to start an FDA-approved ADC as their first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 3: HR+\u002FHER2- mBC Participants enrolled before second line ADC (ADC2))","Participants with histologically documented HR+\u002FHER2- MBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Cohort 4: mTNBC participants enrolled before ADC2","Participants with histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.",[13,14,15],[29,36,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Specimen collection","Blood specimens will be collected during regular clinical visits for correlative and exploratory analysis",[9,17,21,25],[35],"Biospecimen collection",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Non-Investigational Antibody-Drug Conjugates (ADC)","ADC given under usual care for the treatment of cancer",[9,17,21,25],[42],"Non-Investigational ADC",{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Medical Record Review","Prospective and retrospective medical chart reviews will be conducted to obtain data for analysis.",[9,17,21,25],[48],"Medical Chart Review",[50],{"name":51,"affiliation":5,"role":52},"Laura Huppert, MD,BA","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":10,"email":58},"Amy Langdon","CONTACT","(415) 353-7288","Amy.Deluca@ucsf.edu",[60],{"facility":5,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","San Francisco","California","94143","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-122.41942,37.77493,{"lat":71,"lon":70},[74,76,79,81],{"name":55,"role":56,"phone":75,"phoneExt":10,"email":58},"415-353-7288",{"name":10,"role":56,"phone":77,"phoneExt":10,"email":78},"877-827-3222","cancertrials@ucsf.edu",{"name":80,"role":52,"phone":10,"phoneExt":10,"email":10},"Laura Huppert, MD, BA",{"name":82,"role":83,"phone":10,"phoneExt":10,"email":10},"Leif Ellison, MD, PhD","SUB_INVESTIGATOR",{"type":85,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[87,89,92],{"name":88,"class":6},"Translational Breast Cancer Research Consortium",{"name":90,"class":91},"Gilead Sciences","INDUSTRY",{"name":93,"class":6},"Johns Hopkins University","100575572","prospective-registry-of-adc-as-first--and-second-line-treatment-for-breast-cancer-100575572",false,"NCT06774027","Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer","ENCORE: Multicenter ProspectivE Registry of Sequential ANtibody Drug COnjugates (ADCs) in HER2 Negative Metastatic BREast Cancer (MBC)","ENCORE","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study.\n2. Estimated life expectancy of at least at 3 months per investigator assessment.\n3. Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes.\n4. Cohort-specific enrollment criteria:\n\n   * Cohort 1: Histologically documented HR+\u002FHER2- MBC with plan to start an FDA-approved ADC as their first ADC per standard of care (SOC).\n   * Cohort 2: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their first ADC per standard of care\n   * Cohort 3: Histologically documented HR+\u002FHER2- MBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per SOC or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.\n   * Cohort 4: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per standard of care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.\n   * Measurable disease is not required for any cohort.\n\nExclusion Criteria:\n\n1. Prior receipt of an experimental ADC in the metastatic setting. Of note, patients who received an FDA-approved ADC as their first ADC (as monotherapy, not in combination) can participate in cohorts 3 or 4 prior to starting their second FDA-approved ADC per standard of care. Of note, for all cohorts, experimental therapies are not allowed as intervening therapies after starting ADC1. If a patient enrolls on a clinical trial of an experimental therapy after ADC1, they will be taken off study.\n2. Current participation in a clinical trial with an ADC.\n3. Contraindication to research phlebotomy to collect \\~20cc blood at each research blood draw timepoint.",true,"ALL","18 Years",{"count":106,"type":107},100,"ESTIMATED","5 Years","OBSERVATIONAL","Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive\u002FHER2 negative (HR+\u002FHER2-) metastatic breast cancer (MBC), offering an effective new treatment strategy. Several outstanding questions drive the decision to use ADC drugs clinically. This is a prospective, multi-site observational study of patients with metastatic breast cancer (mBC) who are being treated with FDA-approved antibody drug conjugates (ADCs) as part of routine care and aims to collect real-world data to evaluate the impact of ADC treatment as part of routine care.",[112,113,114,115,116,117],"HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Metastatic Breast Cancer","HR+ HER2 Breast Cancer","Metastatic Triple Negative Breast Cancers","Metastatic Triple-Negative Breast Carcinoma","2025-12-10",{"date":120,"type":121},"2025-12-18","ACTUAL",{"date":123,"type":121},"2025-10-08",{"date":125,"type":107},"2030-12-31",{"name":5,"class":6},1]