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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 主要终点
- Percentage of Participants With Inadequate Estrogen Suppression
研究概览
简要总结
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.
详细描述
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.
All 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.
Approximately 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/obesity. 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.
Weight 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.
The primary outcome is the proportion of participants with inadequate estrogen suppression, defined as a serum estradiol concentration greater than 2.72 pg/mL after approximately three months of treatment. This proportion will be compared between participants with normal BMI and those with overweight/obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female sex. Age 18 years or older. Histologically confirmed hormone receptor-positive invasive breast cancer, defined as estrogen receptor-positive and/or progesterone receptor-positive disease, regardless of human epidermal growth factor receptor 2 status.
- •Premenopausal status at the initiation of ovarian suppression, as determined by menstrual history and/or laboratory criteria according to medical assessment.
- •Indication for adjuvant treatment with an aromatase inhibitor (anastrozole, letrozole, or exemestane) combined with pharmacologic ovarian suppression using a gonadotropin-releasing hormone analog.
- •Continuous use of an aromatase inhibitor and a gonadotropin-releasing hormone analog for at least 3 months before the primary study assessment.
- •Documented body mass index at enrollment. Ability to understand the study information and provide written informed consent.
排除标准
- •Postmenopausal status at the initiation of endocrine therapy. Known endocrine disorders that may interfere with the production or metabolism of sex steroids.
- •Concomitant use of medications known to interfere with estradiol metabolism or measurement, including systemic corticosteroids at supraphysiologic doses.
- •Metastatic disease at enrollment. Technical or logistical inability to undergo serum estradiol measurement using an ultrasensitive laboratory method.
- •Concurrent participation in another clinical study that may interfere with the hormonal outcomes evaluated in this study.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Percentage of Participants With Inadequate Estrogen Suppression
时间窗: At 3 months of treatment (visit window: ±14 days)
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.
次要结局
- Serum Estradiol Concentration by Body Mass Index Category(At 3 months of treatment (visit window: ±14 days))
- Correlation Between Body Mass Index and Serum Estradiol Concentration(At 3 months of treatment (visit window: ±14 days))
- Body Mass Index Cutoff Associated With Inadequate Estrogen Suppression(At 3 months of treatment (visit window: ±14 days))
- Association Between Clinical Characteristics and Inadequate Estrogen Suppression(At 3 months of treatment (visit window: ±14 days))
- Serum Estradiol Outcomes in Prespecified Clinical Subgroups(At 3 months of treatment (visit window: ±14 days))