[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07524855":3,"trial-entities:NCT07524855":160,"trial-summary:NCT07524855":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":49,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":95,"locations":98,"central_contacts":148,"overall_officials":154,"references":158,"see_also_links":159},"NCT07524855","HLD-0117-ONC-101","A Study of HLD-0117 in Patients With Metastatic Breast Cancer","A Phase 1a\u002F1b Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)","RECRUITING","2029-10-10","2026-08","2026-08-17","2026-04-09","Janssen Research & Development, LLC","INDUSTRY",true,"Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.","This study is an open-label, dose-escalation and cohort expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of oral single-agent, HLD-0117 in patients with ER+ MBC that have progressed after at least 1 prior systemic line of therapy.\n\nDuring dose escalation, patients will be enrolled into monotherapy cohorts using a Bayesian optimal interval (BOIN) design. Cohorts will enroll a minimum of three patients, with staggered enrollment between cohorts. Backfilling into dose levels determined to be safe may occur to further characterize tolerability and efficacy.\n\nThe purpose of the study is to determine the maximum tolerated dose (MTD) and\u002For recommended dose(s) for expansion (RDEs) of HLD-0117 as a monotherapy.",[19],"Metastatic Breast Cancer",[21,22,23,24,25,26],"breast cancer","RIPTAC","breast carcinoma","locally advanced breast cancer","breast tumor","malignant Tumor of the breast","INTERVENTIONAL","TREATMENT",[30],"PHASE1",{"count":32,"type":33},170,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","HLD-0117","A treatment cycle consists of 28 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[40],"Arm 1",[42,46],{"measure":43,"description":44,"timeFrame":45},"Dose Limiting Toxicities (DLTs)","Frequency of dose-limiting toxicities (DLTs)","28 days",{"measure":47,"description":48,"timeFrame":45},"AEs, ECGs, Labs and Clinical Changes","Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline",[50,54,56,60],{"measure":51,"description":52,"timeFrame":53},"Objective response rate (ORR)","Objective response rate (ORR) per RECIST in evaluable patients","56 Days",{"measure":55,"description":55,"timeFrame":45},"Duration of response (DOR)",{"measure":57,"description":58,"timeFrame":59},"Progression-free survival (rPFS)","Radiographic progression-free survival (rPFS)","56 days",{"measure":61,"description":61,"timeFrame":62},"Disease Control Rate (DCR)","24 weeks","FEMALE","18 Years",null,false,{"inclusion":68,"exclusion":81,"raw_text":94},[69,70,71,72,73,74,75,76,77,78,79,80],"Female (assigned at birth), ≥18 years old, and able to provide informed consent","Histologically confirmed metastatic or locally advanced breast cancer","Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist","Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4\u002F6 inhibitor (in the adjuvant and\u002For metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting","Radiologic disease progression on the most recent therapy","Measurable disease per RECIST v1.1","Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate","ER-positive and HER2-negative status documented within 2 years","ECOG performance status 0-1 and life expectancy of at least 3 months","Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)","Ability to swallow oral medication and comply with study procedures","Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable",[82,83,84,85,86,87,88,89,90,91,92,93],"Inflammatory breast cancer or known brain metastases","Recent major bleeding or uncontrolled bleeding disorder","Ongoing corticosteroid use \\>10 mg\u002Fday (prednisone equivalent)","Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)","Untreated or unstable spinal cord compression","Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions","Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)","Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)","Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)","Major surgery within 28 days","Any condition that may interfere with safety or study compliance","Pregnancy or breastfeeding","Inclusion Criteria:\n\n* Female (assigned at birth), ≥18 years old, and able to provide informed consent\n* Histologically confirmed metastatic or locally advanced breast cancer\n* Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist\n* Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4\u002F6 inhibitor (in the adjuvant and\u002For metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting\n* Radiologic disease progression on the most recent therapy\n* Measurable disease per RECIST v1.1\n* Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate\n* ER-positive and HER2-negative status documented within 2 years\n* ECOG performance status 0-1 and life expectancy of at least 3 months\n* Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)\n* Ability to swallow oral medication and comply with study procedures\n* Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable\n\nExclusion Criteria:\n\n* Inflammatory breast cancer or known brain metastases\n* Recent major bleeding or uncontrolled bleeding disorder\n* Ongoing corticosteroid use \\>10 mg\u002Fday (prednisone equivalent)\n* Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)\n* Untreated or unstable spinal cord compression\n* Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions\n* Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)\n* Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)\n* Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)\n* Major surgery within 28 days\n* Any condition that may interfere with safety or study compliance\n* Pregnancy or breastfeeding",[96,97],"ADULT","OLDER_ADULT",[99,108,116,124,132,140],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Yale University School Of Medicine","New Haven","Connecticut","06510","United States",{"lat":106,"lon":107},41.30815,-72.92816,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":104,"geoPoint":113},"Florida Cancer Specialists","Sarasota","Florida","34236",{"lat":114,"lon":115},27.33643,-82.53065,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":104,"geoPoint":121},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":122,"lon":123},42.35843,-71.05977,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":104,"geoPoint":129},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"lat":130,"lon":131},36.16589,-86.78444,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":104,"geoPoint":137},"South Texas Accelerated Research Therapeutics, LLC (START)","San Antonio","Texas","78229",{"lat":138,"lon":139},29.42412,-98.49363,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":104,"geoPoint":145},"Next Virginia","Fairfax","Virginia","22031",{"lat":146,"lon":147},38.84622,-77.30637,[149],{"name":150,"role":151,"phone":152,"email":153},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[155],{"name":156,"affiliation":13,"role":157},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":161,"biomarkers":163},[162],"Breast Carcinoma",[164],"ESR1 Gene",{"nct_id":4,"found":15,"summary":166,"prompt_version":176},{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is an open-label study, meaning you and your doctors will know you are receiving HLD-0117. It will involve a small number of participants, with at least three in each dose group, to find the best dose.","completed","A Study of HLD-0117 for Metastatic Breast Cancer","This study is testing a drug called HLD-0117 for women with metastatic (spread to other parts of the body) or locally advanced breast cancer that is estrogen receptor positive (ER+). You may be able to join if you are at least 18 years old, postmenopausal, and your cancer has grown despite previous treatments, including at least one endocrine therapy and a CDK4\u002F6 inhibitor. The main goals are to find out the safest dose of HLD-0117 and to see how well it works. The study is currently unclear on its recruitment status and plans to enroll 33 participants.","Safety will be checked for at least 28 days, including side effects, heart readings (ECGs), and lab tests.",97,"You would receive HLD-0117 in 28-day cycles. Treatment may continue until your disease progresses or you need to stop for other reasons, such as side effects.","Not stated in the trial record.",[37],"v2"]