Early Breast CancerEMETANCT06623903
Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy
An observational study of Early Breast Cancer and Metabolic Health, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer, Metabolic Health, Estrogen Receptor Positive Breast Cancer
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2024to 31 Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early breast cancer patients consulted at Dept. of Oncology Aarhus University Hospital from autumn 2024 and 6 months ahead regarding adjuvant treatment.
Who may be able to join
- Age ≥18 years
- Invasive ER+ breast cancer
- No diabetes treatment
- Planned for initiation of any adjuvant endocrine therapy.
Who cannot join
- Pregnancy or lactation,
- Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Aarhus University Hosptial
Aarhus N, Central Jutland, 8200
Signe Borgquist, Clinical Chair Professor, Ph.D, (+45) 91 16 72 94, Signe.borgquist@auh.rm.dk
Lærke S Nissen, BS.c., Research year student, (+45) 61 11 29 28, laenis@rm.dk
About this study
Official title: Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study
This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.
Read the detailed description
Metabolic health, closely tied to overweight and type 2 diabetes, significantly influences disease risks, notably breast cancer. With over 2.5 billion overweight adults globally, the prevalence of associated health concerns is escalating. Breast cancer, the leading cause of female cancer-related mortality, is intricately linked to metabolic factors, including overweight and diabetes, particularly affecting estrogen receptor-positive tumors. Conversely, endocrine therapy as breast cancer treatment can exacerbate metabolic issues, increasing weight gain and the risk of type 2 diabetes. Despite its efficacy in reducing recurrence risk, endocrine therapy is associated with adverse metabolic effects, including elevated cholesterol levels. Estrogen, pivotal in metabolic homeostasis, remains poorly understood in the context of endocrine therapy and metabolic disruptions. This prospective study aims to elucidate this relationship, focusing on the initiation of endocrine therapy, metabolic health, and estradiol levels among early-stage breast cancer patients. Early breast cancer patients initiating endocrine therapy at Aarhus University Hospital from autumn 2024 and six months ahead will be extended an invitation for study participation, with immediate measurements. Metabolic health will be analyzed through weight, hip and waist circumference measurements, blood sugar, cholesterol, and estrogen at baseline and 3-month follow-up. Thorough data collection, including demographics, treatment modalities, and cancer characteristics, ensures a comprehensive understanding of this complex interplay. With 112 projected participants, this study aims to shed light on the intricate connections between endocrine therapy, patient characteristics, and metabolic health changes. Through this comprehensive approach, the investigators aim to enhance patient care and understanding of managing metabolic health alongside breast cancer treatment.
- Keywords
- Early breast cancer, Metabolic health, Endocrine therapy
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Early breast cancer patients initiating endocrine therapy | Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic health changes
A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Waist and hip circumference
A change in waist- and hip circumference compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Blood pressure
A change in blood pressure compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HbA1c
A change in circulating levels of glycated hemoglobin (HbA1c)
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Cholestrerol
A change in blood cholesterol compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Triglycerides
A change in triglycerides compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
LDL
A change in low-density lipoprotein (LDL) compared to baseline.
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HDL
A change in and high-density lipoprotein (HDL) compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Body Mass Index
A change in Body Mass Index (Height and weight combined, kg/m2)
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Secondary outcomes (1)
Estrogen level
Changes in circulating estrogen compared to baseline
Measured: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 112 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Signe Borgquist, Aarhus University Hospital
- Investigators
- Signe Borgquist, Clinical Chair Professor, Ph.D, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623903
- Sponsor's protocol ID
- 1-10-72-122-24
- Other IDs
- 09-2247
- Acronym
- EMETA
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nissen L, Busk Holm J, Borgquist S. Exploring the Impact of Initiating Endocrine Therapy on Metabolic Health in Early Breast Cancer: Protocol for the Prospective Follow-Up EMETA-Study. JMIR Res Protoc. 2026 Mar 25;15:e78589. doi: 10.2196/78589.
PubMed 41880605
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study
- ClinicalTrials.gov ID
- NCT06623903
- Acronym / sponsor ID
- EMETA / 1-10-72-122-24
- Keywords
- Early breast cancer, Metabolic health, Endocrine therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 2 Oct 2024 (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.
This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.
Detailed description
Metabolic health, closely tied to overweight and type 2 diabetes, significantly influences disease risks, notably breast cancer. With over 2.5 billion overweight adults globally, the prevalence of associated health concerns is escalating. Breast cancer, the leading cause of female cancer-related mortality, is intricately linked to metabolic factors, including overweight and diabetes, particularly affecting estrogen receptor-positive tumors. Conversely, endocrine therapy as breast cancer treatment can exacerbate metabolic issues, increasing weight gain and the risk of type 2 diabetes. Despite its efficacy in reducing recurrence risk, endocrine therapy is associated with adverse metabolic effects, including elevated cholesterol levels. Estrogen, pivotal in metabolic homeostasis, remains poorly understood in the context of endocrine therapy and metabolic disruptions. This prospective study aims to elucidate this relationship, focusing on the initiation of endocrine therapy, metabolic health, and estradiol levels among early-stage breast cancer patients. Early breast cancer patients initiating endocrine therapy at Aarhus University Hospital from autumn 2024 and six months ahead will be extended an invitation for study participation, with immediate measurements. Metabolic health will be analyzed through weight, hip and waist circumference measurements, blood sugar, cholesterol, and estrogen at baseline and 3-month follow-up. Thorough data collection, including demographics, treatment modalities, and cancer characteristics, ensures a comprehensive understanding of this complex interplay. With 112 projected participants, this study aims to shed light on the intricate connections between endocrine therapy, patient characteristics, and metabolic health changes. Through this comprehensive approach, the investigators aim to enhance patient care and understanding of managing metabolic health alongside breast cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early breast cancer patients initiating endocrine therapy | – | –Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early breast cancer patients consulted at Dept. of Oncology Aarhus University Hospital from autumn 2024 and 6 months ahead regarding adjuvant treatment.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Invasive ER+ breast cancer
- No diabetes treatment
- Planned for initiation of any adjuvant endocrine therapy.
Key exclusion criteria (2 listed)
- Pregnancy or lactation,
- Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
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
Metabolic health changes
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.
Waist and hip circumference
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in waist- and hip circumference compared to baseline
Blood pressure
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in blood pressure compared to baseline
HbA1c
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in circulating levels of glycated hemoglobin (HbA1c)
Cholestrerol
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in blood cholesterol compared to baseline
Triglycerides
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in triglycerides compared to baseline
LDL
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in low-density lipoprotein (LDL) compared to baseline.
HDL
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in and high-density lipoprotein (HDL) compared to baseline
Body Mass Index
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in Body Mass Index (Height and weight combined, kg/m2)
1 secondary outcome
Estrogen level
Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 41880605Nissen L, Busk Holm J, Borgquist S. Exploring the Impact of Initiating Endocrine Therapy on Metabolic Health in Early Breast Cancer: Protocol for the Prospective Follow-Up EMETA-Study. JMIR Res Protoc. 2026 Mar 25;15:e78589. doi: 10.2196/78589.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Signe Borgquist, Clinical Chair Professor, Ph.D principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer and Metabolic Health, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lærke S Nissen, BS.c., Research Year Student ((+45) 61 11 29 28, laenis@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic health changes (time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)). The study lists 9 primary outcomes in all. 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 NCT06623903, which also lists 1 linked publication.
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 2 Oct 2024.