Estradiol Levels According to Body Mass Index in Premenopausal Patients With Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorD'Or Institute for Research and Education
About this trial
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.
Approximately 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.
The primary objective is to compare the proportion of participants with serum estradiol levels above 2.72 pg/mL 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
172 Participants
are grouped into 2 trial groupsGroup A: Normal BMI
Group B: Overweight or Obesity
Trial outcomes
Primary outcomes
1
Percentage of Participants With Inadequate Estrogen Suppression
Percentage of participants with a serum estradiol concentration greater than 2.72 pg/mL 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/mL 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.
Time frame
At 3 months of treatment (visit window: ±14 days)Secondary outcomes
1
Serum Estradiol Concentration by Body Mass Index Category
Serum estradiol concentration, measured in pg/mL using an ultrasensitive laboratory method, will be summarized and compared across body mass index categories.
Time frame
At 3 months of treatment (visit window: ±14 days)2
Correlation Between Body Mass Index and Serum Estradiol Concentration
The relationship between body mass index, measured in kg/m², and serum estradiol concentration, measured in pg/mL, will be assessed using Spearman's correlation coefficient. The coefficient ranges from -1 to 1, with higher positive values indicating a stronger positive association.
Time frame
At 3 months of treatment (visit window: ±14 days)3
Body Mass Index Cutoff Associated With Inadequate Estrogen Suppression
A potential body mass index cutoff, measured in kg/m², associated with serum estradiol greater than 2.72 pg/mL 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.
Time frame
At 3 months of treatment (visit window: ±14 days)4
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/mL, 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.
Time frame
At 3 months of treatment (visit window: ±14 days)Locations
Sponsors and contacts
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D'Or Institute for Research and Education
Lead sponsor
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Collaborator
Source ClinicalTrials.gov
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