[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656967":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":29,"overallOfficials":42,"centralContacts":50,"locations":29,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":29,"enrollmentInfo":73,"targetDuration":76,"studyType":77,"phases":29,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":91,"whyStopped":29,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":29},{"fullName":5,"class":6},"D'Or Institute for Research and Education","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Inadequate Estrogen Suppression","Percentage of participants with a serum estradiol concentration greater than 2.72 pg\u002FmL after approximately 3 months of treatment with an aromatase inhibitor and pharmacologic ovarian suppression. Serum estradiol will be measured using an ultrasensitive laboratory method. The percentage will be calculated as the number of participants with estradiol greater than 2.72 pg\u002FmL divided by the number of evaluable participants in each body mass index group, multiplied by 100. Results will be compared between participants with normal body mass index and those with overweight or obesity.","At 3 months of treatment (visit window: ±14 days)",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Serum Estradiol Concentration by Body Mass Index Category","Serum estradiol concentration, measured in pg\u002FmL using an ultrasensitive laboratory method, will be summarized and compared across body mass index categories.",{"measure":18,"description":19,"timeFrame":12},"Correlation Between Body Mass Index and Serum Estradiol Concentration","The relationship between body mass index, measured in kg\u002Fm², and serum estradiol concentration, measured in pg\u002FmL, will be assessed using Spearman's correlation coefficient. The coefficient ranges from -1 to 1, with higher positive values indicating a stronger positive association.",{"measure":21,"description":22,"timeFrame":12},"Body Mass Index Cutoff Associated With Inadequate Estrogen Suppression","A potential body mass index cutoff, measured in kg\u002Fm², associated with serum estradiol greater than 2.72 pg\u002FmL will be explored using receiver operating characteristic curve analysis. The analysis will include estimation of the area under the curve, sensitivity, and specificity of the identified cutoff.",{"measure":24,"description":25,"timeFrame":12},"Association Between Clinical Characteristics and Inadequate Estrogen Suppression","Associations between prespecified clinical characteristics and inadequate estrogen suppression, defined as serum estradiol greater than 2.72 pg\u002FmL, will be evaluated using binary logistic regression. Results will be reported as odds ratios with 95% confidence intervals. Evaluated characteristics may include body mass index, age, previous chemotherapy, endocrine treatment characteristics, concomitant medications, and other clinically relevant potential confounders collected according to the protocol.",{"measure":27,"description":28,"timeFrame":12},"Serum Estradiol Outcomes in Prespecified Clinical Subgroups","Serum estradiol concentration and the percentage of participants with estradiol greater than 2.72 pg\u002FmL will be explored in subgroups defined by previous chemotherapy, physical activity, and use of glucagon-like peptide-1 receptor agonists. These analyses are exploratory.",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","This is a multicenter, prospective, observational cohort study designed to evaluate the association between body mass index (BMI) and serum estradiol levels in premenopausal women with hormone receptor-positive invasive breast cancer receiving adjuvant endocrine therapy with an aromatase inhibitor combined with pharmacologic ovarian suppression using a gonadotropin-releasing hormone analog.\n\nAll endocrine treatments will be prescribed as part of routine clinical care. Participation in the study will not determine the selection, dose, schedule, continuation, or modification of anticancer treatment. No experimental intervention, treatment allocation, or randomization is planned.\n\nApproximately 172 participants will be enrolled. For the primary analysis, participants will be classified according to World Health Organization BMI categories and grouped as having normal BMI or overweight\u002Fobesity. At enrollment, demographic, anthropometric, clinical, and oncologic information will be collected, including tumor characteristics, previous cancer treatment, type and timing of aromatase inhibitor and ovarian suppression therapy, concomitant medications, physical activity, and use of glucagon-like peptide-1 receptor agonists.\n\nWeight and height will be measured to calculate BMI. Serum estradiol will be assessed using an ultrasensitive laboratory method. A baseline estradiol measurement may be obtained when applicable, depending on the timing of enrollment. The main estradiol assessment will be performed after approximately three months of combined aromatase inhibitor therapy and pharmacologic ovarian suppression, within a protocol-defined visit window of plus or minus 14 days. If a result suggests inadequate estrogen suppression, an additional measurement may be requested within 14 days using a different laboratory method, according to institutional practice and local availability.\n\nThe primary outcome is the proportion of participants with inadequate estrogen suppression, defined as a serum estradiol concentration greater than 2.72 pg\u002FmL after approximately three months of treatment. This proportion will be compared between participants with normal BMI and those with overweight\u002Fobesity.\n\nSecondary and exploratory analyses will evaluate absolute estradiol concentrations across BMI categories, the correlation between BMI and serum estradiol, a potential BMI cutoff associated with inadequate estrogen suppression, and clinical characteristics associated with inadequate suppression. Exploratory subgroup analyses will consider previous chemotherapy, physical activity, and use of glucagon-like peptide-1 receptor agonists.\n\nThe primary comparison will use a chi-square test or Fisher's exact test, as appropriate. Binary logistic regression will assess the association between BMI and inadequate estrogen suppression, with BMI evaluated as both a categorical and continuous variable and adjustment for clinically relevant potential confounders. Continuous outcomes will be analyzed using parametric or nonparametric methods according to their distributions. The relationship between BMI and estradiol concentration will also be assessed using Spearman correlation, and receiver operating characteristic curve analysis will be used to explore a potential BMI cutoff associated with inadequate estrogen suppression.","Premenopausal adult women with histologically confirmed hormone receptor-positive invasive breast cancer receiving adjuvant endocrine therapy with an aromatase inhibitor combined with pharmacologic ovarian suppression using a gonadotropin-releasing hormone analog. Potential participants will be identified during routine outpatient visits at participating oncology centers in Brazil. Participants will be classified according to World Health Organization body mass index categories and analyzed in two groups: normal body mass index and overweight or obesity.",[36,39],{"label":37,"type":29,"description":38,"interventionNames":29},"Normal BMI","Premenopausal participants with hormone receptor-positive breast cancer receiving an aromatase inhibitor and pharmacologic ovarian suppression who have a body mass index within the normal range according to World Health Organization criteria.",{"label":40,"type":29,"description":41,"interventionNames":29},"Overweight or Obesity","Premenopausal participants with hormone receptor-positive breast cancer receiving an aromatase inhibitor and pharmacologic ovarian suppression who are classified as having overweight or obesity according to World Health Organization body mass index criteria.",[43,47],{"name":44,"affiliation":45,"role":46},"Luísa C.D.F Costa, MD","Institute of Cancer of São Paulo","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":49,"role":46},"Renata C bonadio","D'Or Institute for Research and Education (IDOR)",[51],{"name":52,"role":53,"phone":54,"phoneExt":29,"email":55},"Guilherme C Ambrósio, MSc","CONTACT","11972763211","guilherme.ambrosio@idor.org",{"type":57,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[59],{"name":60,"class":61},"Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)","UNKNOWN","100656967","estradiol-levels-according-to-body-mass-index-in-premenopausal-patients-with-breast-cancer-100656967",false,"NCT07833501","Estradiol Levels According to Body Mass Index in Premenopausal Patients With Breast Cancer","Evaluation of Serum Estradiol Levels According to Body Mass Index Categories in Premenopausal Patients With Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitors and Pharmacologic Ovarian Suppression","SIMPEC-E2","Inclusion Criteria:\n\nFemale sex. Age 18 years or older. Histologically confirmed hormone receptor-positive invasive breast cancer, defined as estrogen receptor-positive and\u002For progesterone receptor-positive disease, regardless of human epidermal growth factor receptor 2 status.\n\nPremenopausal status at the initiation of ovarian suppression, as determined by menstrual history and\u002For laboratory criteria according to medical assessment.\n\nIndication for adjuvant treatment with an aromatase inhibitor (anastrozole, letrozole, or exemestane) combined with pharmacologic ovarian suppression using a gonadotropin-releasing hormone analog.\n\nContinuous use of an aromatase inhibitor and a gonadotropin-releasing hormone analog for at least 3 months before the primary study assessment.\n\nDocumented body mass index at enrollment. Ability to understand the study information and provide written informed consent.\n\nExclusion Criteria:\n\nPostmenopausal status at the initiation of endocrine therapy. Known endocrine disorders that may interfere with the production or metabolism of sex steroids.\n\nConcomitant use of medications known to interfere with estradiol metabolism or measurement, including systemic corticosteroids at supraphysiologic doses.\n\nMetastatic disease at enrollment. Technical or logistical inability to undergo serum estradiol measurement using an ultrasensitive laboratory method.\n\nConcurrent participation in another clinical study that may interfere with the hormonal outcomes evaluated in this study.",true,"FEMALE","18 Years",{"count":74,"type":75},172,"ESTIMATED","3 Months","OBSERVATIONAL","his prospective observational study will evaluate whether body mass index (BMI) is associated with serum estradiol levels in premenopausal women with hormone receptor-positive breast cancer. Participants will already be receiving standard adjuvant treatment with an aromatase inhibitor and pharmacologic ovarian suppression as part of their routine clinical care. The study will not assign or modify cancer treatment.\n\nApproximately 172 participants will be enrolled at multiple study sites in Brazil. They will be classified into two main groups: normal BMI and overweight or obesity. Clinical information, medication use, physical activity, weight, height, and serum estradiol levels will be recorded. Estradiol will be measured using an ultrasensitive laboratory method, with the main assessment occurring after approximately three months of treatment.\n\nThe primary objective is to compare the proportion of participants with serum estradiol levels above 2.72 pg\u002FmL between the two BMI groups. The study will also examine the relationship between BMI and absolute estradiol levels and explore whether clinical characteristics, previous chemotherapy, physical activity, or use of glucagon-like peptide-1 receptor agonists are associated with inadequate estrogen suppression.",[80],"Hormone Receptor-Positive Breast Cancer",[82,83,84,85,86,80,87,88,89,90],"Estradiol","Body Mass Index","Premenopausal Women","Aromatase Inhibitors","Ovarian Suppression","Endocrine Therapy","Overweight","Obesity","Gonadotropin-Releasing Hormone Analogs","NOT_YET_RECRUITING","2026-09-16",{"date":94,"type":95},"2026-09-22","ACTUAL",{"date":97,"type":75},"2026-09-03",{"date":99,"type":75},"2027-05-30",{"name":5,"class":6}]