Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor-Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Normal BMI
- description
- 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
- Overweight or Obesity
- description
- 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.
Primary outcomes (1)
- measure
- Percentage of Participants With Inadequate Estrogen Suppression
- timeFrame
- At 3 months of treatment (visit window: ±14 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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.
References
Publications (5)
- BACKGROUNDBurstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, Colleoni M, Denkert C, Piccart-Gebhart M, Regan M, Senn HJ, Winer EP, Thurlimann B; Members of the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer 2019. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019 Oct 1;30(10):1541-1557. doi: 10.1093/annonc/mdz235. PMID 31373601
- BACKGROUNDChumsri S, Howes T, Bao T, Sabnis G, Brodie A. Aromatase, aromatase inhibitors, and breast cancer. J Steroid Biochem Mol Biol. 2011 May;125(1-2):13-22. doi: 10.1016/j.jsbmb.2011.02.001. Epub 2011 Feb 16. PMID 21335088
- BACKGROUNDLin J, Zheng S, Liu Q. Incomplete ovarian function suppression in premenopausal breast cancer patients treated with gonadotropin-releasing hormone agonists. Cancer Treat Rev. 2025 Feb;133:102879. doi: 10.1016/j.ctrv.2025.102879. Epub 2025 Jan 4. PMID 39793457
- BACKGROUNDMcCann KE, Goldfarb SB, Traina TA, Regan MM, Vidula N, Kaklamani V. Selection of appropriate biomarkers to monitor effectiveness of ovarian function suppression in pre-menopausal patients with ER+ breast cancer. NPJ Breast Cancer. 2024 Jan 19;10(1):8. doi: 10.1038/s41523-024-00614-w. PMID 38242892
- BACKGROUNDBellet M, Gray KP, Francis PA, Lang I, Ciruelos E, Lluch A, Climent MA, Catalan G, Avella A, Bohn U, Gonzalez-Martin A, Ferrer R, Catalan R, Azaro A, Rajasekaran A, Morales J, Vazquez J, Fleming GF, Price KN, Regan MM. Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy. J Clin Oncol. 2016 May 10;34(14):1584-93. doi: 10.1200/JCO.2015.61.2259. Epub 2016 Jan 4. PMID 26729437