[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633598":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":47,"overallOfficials":55,"centralContacts":60,"locations":70,"responsibleParty":131,"collaborators":135,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":26,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":26,"enrollmentInfo":151,"targetDuration":26,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":169,"whyStopped":26,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"AntiCancer Research Jamaica","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.","Up to 5 years",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Overall Survival (OS)","Time from randomization to death from any cause",{"measure":18,"description":19,"timeFrame":12},"Quality of Life Score on EORTC QLQ-C30","Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Covers 5 functional scales (Physical, Role, Cognitive, Emotional and Social), 3 symptom scales (Fatigue, Pain and Nausea\u002FVomiting) and a global health status scale. All are scored from 0 to 100 with higher scores corresponding to higher functioning or better quality of life on the functional and global health scales, and higher scores indicating greater severity of symptoms on the symptom scales.",{"measure":21,"description":22,"timeFrame":12},"Quality of Life Score on EORTC QLQ-BR23","Quality of life assessed using the EORTC Quality of Life Questionnaire breast cancer-specific module (QLQ-BR23). This includes 4 functional scales (Body Image, Future Perspective, Sexual Functioning and Sexual Enjoyment) 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms and Breast Symptoms). All scales are scored from 0 to 100, with a high score representing higher functioning\u002Fbetter quality of life on the functional scales and worse symptoms on the symptom scales.",{"measure":24,"description":25,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0","Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","This is a Phase II, randomized, open-label, multicentre clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for Caribbean women of African ancestry with metastatic triple-negative breast cancer (TNBC).\n\nEligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Trinidad and Tobago). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.\n\nParticipants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.\n\nTumour assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.\n\nParticipants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Intervention - Gemcitabine","EXPERIMENTAL","Gemcitabine 1000 mg\u002Fm² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal",[40],"Drug: Gemcitabine (1000 mg\u002Fm^2)",{"label":42,"type":43,"description":44,"interventionNames":45},"Control - Paclitaxel","ACTIVE_COMPARATOR","Paclitaxel 80 mg\u002Fm² IV weekly or docetaxel 75 mg\u002Fm² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal",[46],"Drug: Paclitaxel 80 mg\u002Fm2 weekly",[48,52],{"type":49,"name":50,"description":38,"armGroupLabels":51,"otherNames":26},"DRUG","Gemcitabine (1000 mg\u002Fm^2)",[36],{"type":49,"name":53,"description":44,"armGroupLabels":54,"otherNames":26},"Paclitaxel 80 mg\u002Fm2 weekly",[42],[56],{"name":57,"affiliation":58,"role":59},"Magdalene Nwokocha, DM, MBBS","University Hospital of the West Indies","STUDY_DIRECTOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":26,"email":65},"Simone Badal, PhD","CONTACT","1-876-325-7366","simone.badal@uwi.edu",{"name":67,"role":63,"phone":68,"phoneExt":26,"email":69},"Alison E Ayoub, MSc","876-553-7242","alison.ayoub@uwi.edu",[71,87,110],{"facility":72,"status":26,"city":73,"state":74,"zip":26,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"The Queen Elizabeth Hospital","Bridgetown","Saint Michael","Barbados","BB",{"type":78,"coordinates":79},"Point",[80,81],-59.62021,13.10732,{"lat":81,"lon":80},[84],{"name":85,"role":63,"phone":26,"phoneExt":26,"email":86},"Simon Anderson, PhD","simon.anderson@cavehill.uwi.edu",{"facility":88,"status":26,"city":89,"state":90,"zip":26,"country":91,"countryCode":92,"cosmosGeoPoint":26,"geoPoint":26,"contacts":93},"The University of the West Indies, Mona","Mona","Kingston","Jamaica","JM",[94,96,98,101,102,104,106,108],{"name":62,"role":63,"phone":95,"phoneExt":26,"email":65},"876-325-7366",{"name":67,"role":63,"phone":97,"phoneExt":26,"email":69},"8765537242",{"name":99,"role":100,"phone":26,"phoneExt":26,"email":26},"Dwight Lowe, DM, MBBS","SUB_INVESTIGATOR",{"name":57,"role":100,"phone":26,"phoneExt":26,"email":26},{"name":103,"role":100,"phone":26,"phoneExt":26,"email":26},"Derria Cornwall, DM, MBBS",{"name":105,"role":100,"phone":26,"phoneExt":26,"email":26},"Patrick Roberts, DM, MBBS",{"name":107,"role":100,"phone":26,"phoneExt":26,"email":26},"Rory Thompson, DM, MBBS",{"name":109,"role":100,"phone":26,"phoneExt":26,"email":26},"Althea Bailey, PhD",{"facility":111,"status":26,"city":112,"state":113,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"St. James Medical Complex","Port of Spain","Saint James","Trinidad and Tobago","TT",{"type":78,"coordinates":117},[118,119],-61.51889,10.66668,{"lat":119,"lon":118},[122,126],{"name":123,"role":63,"phone":124,"phoneExt":26,"email":125},"Amalia Hoselin, PhD","8687752895","amalia.hosein@utt.edu.tt",{"name":127,"role":63,"phone":128,"phoneExt":129,"email":130},"Rajini Haraksingh, PhD","(868) 662-2002","85243","rajini.haraksingh@sta.uwi.edu",{"type":132,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Simone Badal","Principal Investigator",[136,138,140],{"name":137,"class":6},"Wellcome Trust",{"name":139,"class":6},"The University of The West Indies",{"name":141,"class":6},"Kingston Public Hospital","100633598","phase-2-gemcitabine-vs-paclitaxel-in-caribbean-women-of-african-ancestry-with-metastatic-triple-negative-breast-cancer-100633598",false,"NCT07528768","Gemcitabine vs Paclitaxel in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer","Breaking Barriers in Breast Cancer Treatment for the Caribbean - Gemcitabine Versus Standard First-Line Chemotherapy in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Self-identified Caribbean Black women of Jamaican, Trinidadian, or Barbadian ancestry\n2. Age ≥18 years\n3. Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)\n4. ECOG (Eastern Cooperative Oncology Group) performance status 0-1\n5. No prior systemic therapy for metastatic disease\n6. Adequate organ function (detailed laboratory criteria specified)\n7. Written informed consent\n8. Willingness to provide biospecimens for research\n\nExclusion Criteria:\n\n1. Prior gemcitabine, anthracycline, or taxane treatment in any setting\n2. Active brain metastases requiring immediate treatment\n3. Pregnant or breastfeeding\n4. Concurrent participation in other interventional trials\n5. Medical conditions precluding safe chemotherapy administration\n6. Inability to provide informed consent","FEMALE","18 Years",{"count":152,"type":153},750,"ESTIMATED","INTERVENTIONAL",[156],"PHASE2","The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in Black Caribbean women than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are Caribbean women of African ancestry, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.\n\nThe main questions the trial aims to answer are:\n\n1. Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?\n2. Are participants more likely to get better when taking Gemcitabine or Paclitaxel?\n3. What medical problems do participants have when taking Gemcitabine for breast cancer?\n4. Do Gemcitabine and Paclitaxel affect Black Caribbean women differently than women from other regions or ethnic groups?\n\nTo answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:\n\n* Take Gemcitabine for two weeks followed by a two-week break, or take Paclitaxel once a week for the same time period.\n* Have some of the cancer tissue that was tested from their biopsy taken for more testing.\n* Have a physical exam and a blood test done every 3 weeks.\n* Have images of their cancer taken using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) every 6 weeks.\n* Answer a brief questionnaire about how they are feeling every 8 weeks.\n* Be checked on every month after treatment is finished to make sure the cancer hasn't come back.",[159,160],"Triple Negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[162,163,164,165,166,167,168,91,114,75],"Triple Negative Breast Neoplasms","Gemcitabine","Paclitaxel","Progression-Free Survival","Overall Survival","Quality of Life","Caribbean","NOT_YET_RECRUITING","2026-04-10",{"date":172,"type":173},"2026-04-14","ACTUAL",{"date":175,"type":153},"2026-06-01",{"date":177,"type":153},"2034-06-01",{"name":5,"class":6},3]