[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05142800":3,"trial-entities:NCT05142800":102,"trial-summary:NCT05142800":106},{"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":30,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":54,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":76,"locations":79,"central_contacts":96,"overall_officials":98,"references":100,"see_also_links":101},"NCT05142800","18-195","Screening For BCRL In Targeted Therapy For Breast Cancer","Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","RECRUITING","2026-09-30","2026-07","2026-07-13","2018-12-13","Massachusetts General Hospital","OTHER",false,"This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes","This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished.\n\nA Perometer and Sozo device will be used to measure volume changes\n\nAll participants will be accrued at Massachusetts General Hospital for a target accrual of 166 participants.",[19,20,21,22,23,24,25,26,27,28,29],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage","Breast Cancer",[19,20,21,22,23,24,25,26,27,28,29],"OBSERVATIONAL",null,[],{"count":35,"type":36},261,"ESTIMATED",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DEVICE","Perometer","The perometer uses light sensors to calculate the length and volume of your arms",[43,44],"Target Therapy Drug-Stand Care","Target Therapy-Early or Metastatic Breast Cancer",{"type":39,"name":46,"description":47,"armGroupLabels":48},"SOZO device","The machine measures the amount of fluid on the arm(s)",[43,44],[50],{"measure":51,"description":52,"timeFrame":53},"Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery","Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery","At least three months post surgery up to 5 years, assessed every 3 months",[55,59],{"measure":56,"description":57,"timeFrame":58},"To assess the time course to lymphedema onset","We will also attempt to look at any time course differences of lymphedema onset by plotting cumulative incidence curves of the study and control groups and comparing hazard rates after accounting for important covariates in a multivariate Cox proportional-hazards model.","5 Years",{"measure":60,"description":61,"timeFrame":58},"To asses the correlation of different targeted therapies with lymphedema onset","We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4\u002F6, PI3K, mTOR, AKT).","FEMALE","18 Years","80 Years",{"inclusion":66,"exclusion":74,"raw_text":75},[67,68,69,70,71,72,73],"Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.","Subjects that will be eligible for the study include:","Females between 18 and 80 years of age","With a history of breast cancer","4 weeks or more post-surgery","With or without edema","Undergoing treatment with targeted therapy for early or metastatic disease.",[],"Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":13,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":93},"Boston","Massachusetts","02115","United States",[86,91],{"name":87,"role":88,"phone":89,"email":90},"Alphonse G. Taghian, MD","CONTACT","617-643-1306","ataghian@partners.org",{"name":87,"role":92},"PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},42.35843,-71.05977,[97],{"name":87,"role":88,"phone":89,"email":90},[99],{"name":87,"affiliation":13,"role":92},[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104,19],"Breast Carcinoma",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study designed to track changes in arm volume over time. It aims to enroll 261 participants.","completed","Screening for Lymphedema in Breast Cancer Patients on Targeted Therapy","This study is looking at how often breast cancer patients receiving targeted therapy develop swelling (edema) or breast cancer-related lymphedema (BCRL). Researchers will use two devices, the Perometer and SOZO, to measure arm volume changes in women aged 18 to 80 who are undergoing targeted therapy for early or metastatic breast cancer at Massachusetts General Hospital. The main goal is to see what percentage of participants have a 10% or more increase in arm volume, detected by the Perometer, at least three months after breast surgery and up to five years later. The study's current status is unclear.","Participants will be followed for up to five years after breast surgery, with measurements taken every three months.",98,"You would have your arm volume measured using a Perometer and SOZO device before, during, and for up to six months after your targeted therapy treatment. These measurements will be taken every three months for up to five years.","Not stated in the trial record.",[40],"v2"]