Hormone Receptor-Positive Breast CancerSIMPEC-E2NCT07833501
Estradiol Levels According to Body Mass Index in Premenopausal Patients With Breast Cancer
An observational study of Hormone Receptor-Positive Breast Cancer, run by D'Or Institute for Research and Education.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Receptor-Positive Breast Cancer
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2026to 30 May 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
Secondary 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.
The 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.
- Conditions
- Hormone Receptor-Positive Breast Cancer
- Keywords
- Estradiol, Body Mass Index, Premenopausal Women, Aromatase Inhibitors, Ovarian Suppression, Hormone Receptor-Positive Breast Cancer, Endocrine Therapy, Overweight, Obesity, Gonadotropin-Releasing Hormone Analogs
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months of treatment (visit window: ±14 days)
Secondary outcomes (5)
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.
Measured: At 3 months of treatment (visit window: ±14 days)
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.
Measured: At 3 months of treatment (visit window: ±14 days)
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.
Measured: At 3 months of treatment (visit window: ±14 days)
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.
Measured: At 3 months of treatment (visit window: ±14 days)
Serum Estradiol Outcomes in Prespecified Clinical Subgroups
Serum estradiol concentration and the percentage of participants with estradiol greater than 2.72 pg/mL will be explored in subgroups defined by previous chemotherapy, physical activity, and use of glucagon-like peptide-1 receptor agonists. These analyses are exploratory.
Measured: At 3 months of treatment (visit window: ±14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start3 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hormone Receptor-Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Responsible party
- Sponsor
- Investigators
- Luísa C.D.F Costa, MD, Principal investigator, Institute of Cancer of São PauloRenata C bonadio, Principal investigator, D'Or Institute for Research and Education (IDOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833501
- Sponsor's protocol ID
- SIMPEC-ESTRADIOL-001
- Acronym
- SIMPEC-E2
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available under the current protocol because the informed consent and data governance procedures do not provide for external sharing of individual-level clinical and laboratory data. Study findings will be disseminated in aggregate form to protect participant privacy and confidentiality and to comply with applicable ethical requirements and Brazilian data protection legislation.
Publications
Burstein 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.
PubMed 31373601Chumsri 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.
PubMed 21335088Lin 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.
PubMed 39793457McCann 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.
PubMed 38242892Bellet 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.
PubMed 26729437
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07833501
- Acronym / sponsor ID
- SIMPEC-E2 / SIMPEC-ESTRADIOL-001
- Conditions
- Hormone Receptor-Positive Breast Cancer
- Keywords
- Estradiol, Body Mass Index, Premenopausal Women, Aromatase Inhibitors, Ovarian Suppression, Hormone Receptor-Positive Breast Cancer, Endocrine Therapy, Overweight
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Secondary 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.
The 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Inadequate Estrogen Suppression
Time frame: 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.
5 secondary outcomes
Serum Estradiol Concentration by Body Mass Index Category
Time frame: At 3 months of treatment (visit window: ±14 days)
Correlation Between Body Mass Index and Serum Estradiol Concentration
Time frame: At 3 months of treatment (visit window: ±14 days)
Body Mass Index Cutoff Associated With Inadequate Estrogen Suppression
Time frame: At 3 months of treatment (visit window: ±14 days)
Association Between Clinical Characteristics and Inadequate Estrogen Suppression
Time frame: At 3 months of treatment (visit window: ±14 days)
Serum Estradiol Outcomes in Prespecified Clinical Subgroups
Time frame: At 3 months of treatment (visit window: ±14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 31373601Burstein 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.
- Background: PubMed 21335088Chumsri 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.
- Background: PubMed 39793457Lin 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.
- Background: PubMed 38242892McCann 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.
- Background: PubMed 26729437Bellet 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available under the current protocol because the informed consent and data governance procedures do not provide for external sharing of individual-level clinical and laboratory data. Study findings will be disseminated in aggregate form to protect participant privacy and confidentiality and to comply with applicable ethical requirements and Brazilian data protection legislation.
Related trials for Hormone Receptor-Positive Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luísa C.D.F Costa, MD principal investigator
Institute of Cancer of São Paulo
Renata C bonadio principal investigator
D'Or Institute for Research and Education (IDOR)
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Receptor-Positive Breast Cancer, run by D'Or Institute for Research and Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guilherme C Ambrósio, MSc (11972763211, guilherme.ambrosio@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Inadequate Estrogen Suppression (time frame: At 3 months of treatment (visit window: ±14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07833501, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.