Breast Cancer (Early Breast Cancer)Phase 2WISPERNCT07909889
Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
A Phase 2 study testing Semaglutide (Wegovy®) in people with Breast Cancer (Early Breast Cancer) and Obesity, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
This study will assess whether women with obesity and early estrogen receptor-positive breast cancer can complete 26 weeks of semaglutide treatment while continuing their prescribed hormone therapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer), Obesity
- What is being tested?
- Semaglutide (Wegovy®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2027to Sep 2029
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female diagnosed with estrogen receptor-positive early breast cancer (stage I-III).
- Currently receiving, or planning to initiate, adjuvant endocrine therapy for early estrogen receptor-positive breast cancer, with at least 78 weeks of planned endocrine therapy remaining at randomization.
- Body mass index of at least 30 kg/m² at screening.
- Eastern Cooperative Oncology Group performance status 0-1.
- Age 18 years or older.
- Able to provide oral and written informed consent in Danish.
Who cannot join
- Ongoing treatment with semaglutide or another GLP-1 receptor agonist, or previous use of any pharmacological weight-reducing agent within the last 6 months.
- Type 1 or type 2 diabetes mellitus, or HbA1c of at least 48 mmol/mol.
- Self-reported alcohol intake exceeding 14 units per week, or severe substance abuse.
- Known pregnancy at screening.
- Women of childbearing potential who are unable or unwilling to use contraception.
- Significant somatic disease, defined as any of the following:
Show all 16Show fewer
- End-stage renal failure with estimated glomerular filtration rate below 15 mL/min/1.73 m².
- Alanine or aspartate aminotransferase above twice the upper limit of normal.
- History of acute or chronic pancreatitis.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- New York Heart Association class IV heart failure, unstable angina pectoris, or myocardial infarction within the previous 6 months.
- Uncontrolled hypertension, defined as systolic blood pressure above 180 mmHg or diastolic blood pressure above 100 mmHg.
- Currently breastfeeding.
- Women of childbearing potential who are unable or unwilling to use an effective contraceptive method during semaglutide treatment and for at least 2 months after the last dose.
- Current participation in another interventional drug trial.
- Any circumstance that, in the investigator's judgment, would interfere with trial conduct, participant safety or the validity of trial outcomes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Department of Oncology, Aarhus University Hospital
Aarhus N, 8200
Borgquist, MD, PhD, 2262 4525, signe.borgquist@auh.rm.dk
Sixten Harborg, MD, PhD
Department of Oncology, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: Weight Loss Intervention With Semaglutide in Patients With Estrogen Receptor-positive Breast Cancer (WISPER): A Phase II, Randomized, Open-label, Single-center, Delayed-start Feasibility Trial of Glucagon-like Peptide-1 Receptor Agonist Therapy During Adjuvant Endocrine Therapy.
This study will assess whether women with obesity and early estrogen receptor-positive breast cancer can complete 26 weeks of semaglutide treatment while continuing their prescribed hormone therapy for breast cancer. The researchers expect that semaglutide can be given alongside hormone therapy with good treatment adherence. The study will also examine side effects, weight changes, body composition, metabolic health and quality of life.
Thirty-two women will be randomly assigned to start semaglutide immediately or after a 26-week waiting period. Both groups will continue usual breast cancer care and receive written advice about diet and physical activity. Semaglutide will be self-injected under the skin once a week for 26 weeks, with the dose increased gradually according to tolerability.
Participants will attend visits for weight and body measurements, blood tests, side-effect assessments and questionnaires. Follow-up will continue for 26 weeks after the treatment period. Total follow-up from randomization will be 52 weeks for the immediate-start group and 78 weeks for the delayed-start group. Some participants will also be invited to interviews about their experience of treatment.
Read the detailed description
WISPER is a phase II, randomized, open-label, single-center, delayed-start feasibility trial conducted at the Department of Oncology, Aarhus University Hospital, Denmark. Thirty-two women aged 18 years or older with obesity (body mass index at least 30 kg/m²) and stage I-III estrogen receptor-positive breast cancer will be randomized 1:1 to immediate or delayed semaglutide initiation. Participants must be receiving, or planning to initiate, adjuvant endocrine therapy with at least 78 weeks of planned treatment remaining at randomization.
The immediate-start arm receives once-weekly subcutaneous semaglutide for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. The delayed-start arm receives standard care for 26 weeks, followed by the same 26-week semaglutide regimen and 26 weeks of post-treatment observation. Semaglutide is escalated from 0.25 mg weekly to a target dose of 2.4 mg weekly. Delayed escalation or temporary dose reduction is permitted for tolerability. Both arms continue usual adjuvant endocrine therapy and receive standardized written guidance on diet and physical activity without a supervised lifestyle intervention.
The primary endpoint is a composite feasibility outcome at the end of each arm's 26-week treatment phase: completion of treatment without permanent discontinuation of adjuvant endocrine therapy or semaglutide, with administration of at least 21 of 26 planned weekly semaglutide injections.
Secondary assessments address safety, patient-reported tolerability, recruitment, retention, treatment completion and acceptability, as well as changes in weight, metabolic measures, body composition and quality of life. The randomized comparison during the first 26 weeks contrasts immediate treatment with the waiting period. Additional assessments evaluate each arm's treatment period and subsequent weight maintenance. Exploratory analyses concern semaglutide and endocrine-therapy pharmacokinetics and exposure-response relationships. Stored samples may be used for protocol-specified exploratory biomarker analyses in participants who consent to biobanking.
Trial weeks are measured from randomization. Treatment starts at trial week 0 in the immediate-start arm and trial week 26 in the delayed-start arm. End-of-treatment assessments occur at trial weeks 26 and 52, respectively; end-of-follow-up assessments occur at trial weeks 52 and 78. Participants who discontinue semaglutide are invited to continue scheduled follow-up.
- Conditions
- Breast Cancer (Early Breast Cancer), Obesity
- Being tested
- Semaglutide (Wegovy®)
- Keywords
- GLP1, Obesity, Breast Cancer, Anti-obesity medication, Weight-loss, Metabolic health, Delayed-start trial, Feasibility, GLP-1 receptor agonist, Weight management, Adjuvant endocrine therapy, Estrogen receptor-positive breast cancer, Semaglutide
- Medical subject headings
- Breast Neoplasms, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Wegovy®)Drug
Also called Wegovy
Semaglutide is self-administered by subcutaneous injection once weekly for 26 weeks. Doses are 0.25 mg during treatment weeks 1-4, 0.5 mg during weeks 5-8, 1.0 mg during weeks 9-12, 1.7 mg during weeks 13-16, and a target maintenance dose of 2.4 mg during weeks 17-26. Dose escalation may be delayed or the dose temporarily reduced for significant gastrointestinal symptoms. Treatment starts at randomization in the immediate-start arm and at trial week 26 in the delayed-start arm.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-start semaglutide | Experimental | Participants receive semaglutide once weekly for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. Usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity continue throughout participation. Receives: Drug: Semaglutide (Wegovy®) |
| Delayed-start semaglutide | Experimental | Participants receive standard care alone for the first 26 weeks after randomization, then semaglutide once weekly for 26 weeks, followed by 26 weeks of post-treatment observation. Standard care comprises usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity. Total follow-up is 78 weeks from randomization. Receives: Drug: Semaglutide (Wegovy®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria
Percentage of participants who complete the assigned 26-week treatment phase while meeting all three criteria: no permanent discontinuation of prescribed adjuvant endocrine therapy; no permanent discontinuation of semaglutide; and administration of at least 21 of 26 planned weekly semaglutide injections. Endocrine therapy continuation is assessed from prescription records and self-reported intake; semaglutide adherence is assessed from electronic dosing diaries with pen reconciliation. The proportion will be reported with a 95% confidence interval.
Measured: At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B.
Secondary outcomes (23)
Adverse events during semaglutide treatment and post-treatment follow-up
Number and percentage of participants with adverse events and total number of events, characterized by event type, maximum severity according to CTCAE version 6.0, relationship to semaglutide and event outcome.
Measured: From the first semaglutide dose to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.
Serious adverse events
Number and percentage of participants with at least one serious adverse event and total number of serious adverse events during trial participation.
Measured: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Suspected unexpected serious adverse reactions
Number and percentage of participants with at least one suspected unexpected serious adverse reaction and total number of such reactions during trial participation.
Measured: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Adverse events of special interest
Number and percentage of participants with protocol-defined adverse events of special interest and number of events, reported separately by event category.
Measured: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Patient-reported symptomatic adverse events
Patient-reported symptomatic adverse events assessed using selected PRO-CTCAE items, with frequency, severity, interference or presence reported separately as applicable. Item scores range from 0 to 4, or 0 to 1 for presence/absence, with higher values indicating greater symptom burden.
Measured: At protocol-specified assessments from treatment start to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.
Semaglutide dose interruptions
Number and percentage of participants with a temporary interruption of semaglutide, number of interruptions and recorded reasons.
Measured: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Semaglutide dose reductions
Number and percentage of participants with a reduction in semaglutide dose, number of dose reductions and recorded reasons.
Measured: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of semaglutide
Number and percentage of participants who permanently discontinue semaglutide, with reasons for discontinuation.
Measured: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Time to permanent discontinuation of semaglutide
Time in days from the first semaglutide dose to permanent discontinuation during the assigned treatment phase.
Measured: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of adjuvant endocrine therapy
Number and percentage of participants who permanently discontinue adjuvant endocrine therapy, with reasons for discontinuation. Temporary interruptions or modifications with maintained prescribing intent are not classified as permanent discontinuation.
Measured: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Completion of the semaglutide treatment phase
Percentage of participants who complete the assigned 26-week semaglutide treatment phase, summarized separately by arm.
Measured: At trial week 26 in Arm A and trial week 52 in Arm B.
Participant-reported acceptability of semaglutide treatment
Qualitative themes from semi-structured interviews concerning acceptability, motivation, expectations, concerns, perceived stigma, support needs and barriers to participation. Approximately 10 participants across both arms are expected to be interviewed.
Measured: After treatment completion, within trial weeks 26-52 in Arm A and 52-78 in Arm B.
Participants achieving at least 5% weight loss at trial week 26
Percentage of participants with at least 5% reduction in body weight from randomization baseline to trial week 26, compared between the immediate-start and delayed-start arms. Weight loss is calculated relative to body weight at randomization.
Measured: From randomization to trial week 26 in both arms.
Percentage change in body weight from randomization to trial week 12
Mean percentage change in body weight from randomization baseline to trial week 12, representing early treatment in Arm A and the waiting period in Arm B. Negative values indicate weight loss.
Measured: Randomization baseline and trial week 12 in both arms.
Change in fat mass after 26 weeks of treatment
Fat mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat mass percentage after 26 weeks of treatment
Fat mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat-free mass after 26 weeks of treatment
Fat-free mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat-free mass percentage after 26 weeks of treatment
Fat-free mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in skeletal muscle mass after 26 weeks of treatment
Skeletal muscle mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in EORTC QLQ-C30 Global Health Status and Quality of Life score
Change in the EORTC QLQ-C30 Global Health Status/Quality of Life scale score from treatment start to treatment completion. Scores range from 0 to 100; higher scores indicate better global health status and quality of life. Positive changes indicate improvement.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in EORTC QLQ-BR45 Body Image score
Change in the EORTC QLQ-BR45 Body Image scale score from treatment start to treatment completion. Scores range from 0 to 100; higher scores indicate better body image. Positive changes indicate improvement.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fasting plasma glucose after 26 weeks of treatment
Fasting plasma glucose, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in total cholesterol after 26 weeks of treatment
Total cholesterol, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
Measured: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Early Breast Cancer)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized 1:1 to immediate-start semaglutide or delayed-start semaglutide after 26 weeks of standard care. Each arm receives semaglutide for 26 weeks followed by 26 weeks of post-treatment observation. The first 26 weeks provide a randomized comparison of immediate treatment with standard care.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Danish Comprehensive Cancer Center, Obesity and Cancer Network (ObeCaRe)
- Responsible party
- Principal investigator, Signe Borgquist, Aarhus University Hospital
- Investigators
- Signe Borgquist, MD, PhD, Principal investigator, Aarhus University HospitalSixten Harborg, MD, PhD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909889
- Sponsor's protocol ID
- SBSHWISPER
- Acronym
- WISPER
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Intervention With Semaglutide in Patients With Estrogen Receptor-positive Breast Cancer (WISPER): A Phase II, Randomized, Open-label, Single-center, Delayed-start Feasibility Trial of Glucagon-like Peptide-1 Receptor Agonist Therapy During Adjuvant Endocrine Therapy.
- ClinicalTrials.gov ID
- NCT07909889
- Acronym / sponsor ID
- WISPER / SBSHWISPER
- Conditions
- Breast Cancer (Early Breast Cancer), Obesity
- Keywords
- GLP1, Obesity, Breast Cancer, Anti-obesity medication, Weight-loss, Metabolic health, Delayed-start trial, Feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Danish Comprehensive Cancer Center, Obesity and Cancer Network (ObeCaRe)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Nov 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.
This study will assess whether women with obesity and early estrogen receptor-positive breast cancer can complete 26 weeks of semaglutide treatment while continuing their prescribed hormone therapy for breast cancer. The researchers expect that semaglutide can be given alongside hormone therapy with good treatment adherence. The study will also examine side effects, weight changes, body composition, metabolic health and quality of life.
Thirty-two women will be randomly assigned to start semaglutide immediately or after a 26-week waiting period. Both groups will continue usual breast cancer care and receive written advice about diet and physical activity. Semaglutide will be self-injected under the skin once a week for 26 weeks, with the dose increased gradually according to tolerability.
Participants will attend visits for weight and body measurements, blood tests, side-effect assessments and questionnaires. Follow-up will continue for 26 weeks after the treatment period. Total follow-up from randomization will be 52 weeks for the immediate-start group and 78 weeks for the delayed-start group. Some participants will also be invited to interviews about their experience of treatment.
Detailed description
WISPER is a phase II, randomized, open-label, single-center, delayed-start feasibility trial conducted at the Department of Oncology, Aarhus University Hospital, Denmark. Thirty-two women aged 18 years or older with obesity (body mass index at least 30 kg/m²) and stage I-III estrogen receptor-positive breast cancer will be randomized 1:1 to immediate or delayed semaglutide initiation. Participants must be receiving, or planning to initiate, adjuvant endocrine therapy with at least 78 weeks of planned treatment remaining at randomization.
The immediate-start arm receives once-weekly subcutaneous semaglutide for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. The delayed-start arm receives standard care for 26 weeks, followed by the same 26-week semaglutide regimen and 26 weeks of post-treatment observation. Semaglutide is escalated from 0.25 mg weekly to a target dose of 2.4 mg weekly. Delayed escalation or temporary dose reduction is permitted for tolerability. Both arms continue usual adjuvant endocrine therapy and receive standardized written guidance on diet and physical activity without a supervised lifestyle intervention.
The primary endpoint is a composite feasibility outcome at the end of each arm's 26-week treatment phase: completion of treatment without permanent discontinuation of adjuvant endocrine therapy or semaglutide, with administration of at least 21 of 26 planned weekly semaglutide injections.
Secondary assessments address safety, patient-reported tolerability, recruitment, retention, treatment completion and acceptability, as well as changes in weight, metabolic measures, body composition and quality of life. The randomized comparison during the first 26 weeks contrasts immediate treatment with the waiting period. Additional assessments evaluate each arm's treatment period and subsequent weight maintenance. Exploratory analyses concern semaglutide and endocrine-therapy pharmacokinetics and exposure-response relationships. Stored samples may be used for protocol-specified exploratory biomarker analyses in participants who consent to biobanking.
Trial weeks are measured from randomization. Treatment starts at trial week 0 in the immediate-start arm and trial week 26 in the delayed-start arm. End-of-treatment assessments occur at trial weeks 26 and 52, respectively; end-of-follow-up assessments occur at trial weeks 52 and 78. Participants who discontinue semaglutide are invited to continue scheduled follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to immediate-start semaglutide or delayed-start semaglutide after 26 weeks of standard care. Each arm receives semaglutide for 26 weeks followed by 26 weeks of post-treatment observation. The first 26 weeks provide a randomized comparison of immediate treatment with standard care.
| Arm | Type | Receives |
|---|---|---|
| Immediate-start semaglutide | Experimental | Drug: Semaglutide (Wegovy®)Participants receive semaglutide once weekly for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. Usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity continue throughout participation. |
| Delayed-start semaglutide | Experimental | Drug: Semaglutide (Wegovy®)Participants receive standard care alone for the first 26 weeks after randomization, then semaglutide once weekly for 26 weeks, followed by 26 weeks of post-treatment observation. Standard care comprises usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity. Total follow-up is 78 weeks from randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female diagnosed with estrogen receptor-positive early breast cancer (stage I-III).
- Currently receiving, or planning to initiate, adjuvant endocrine therapy for early estrogen receptor-positive breast cancer, with at least 78 weeks of planned endocrine therapy remaining at randomization.
- Body mass index of at least 30 kg/m² at screening.
- Eastern Cooperative Oncology Group performance status 0-1.
- Age 18 years or older.
Key exclusion criteria (16 listed)
- Ongoing treatment with semaglutide or another GLP-1 receptor agonist, or previous use of any pharmacological weight-reducing agent within the last 6 months.
- Type 1 or type 2 diabetes mellitus, or HbA1c of at least 48 mmol/mol.
- Self-reported alcohol intake exceeding 14 units per week, or severe substance abuse.
- Known pregnancy at screening.
- Women of childbearing potential who are unable or unwilling to use contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Wegovy®)Also: WegovySemaglutide is self-administered by subcutaneous injection once weekly for 26 weeks. Doses are 0.25 mg during treatment weeks 1-4, 0.5 mg during weeks 5-8, 1.0 mg during weeks 9-12, 1.7 mg during weeks 13-16, and a target maintenance dose of 2.4 mg during weeks 17-26. Dose escalation may be delayed or the dose temporarily reduced for significant gastrointestinal symptoms. Treatment starts at randomization in the immediate-start arm and at trial week 26 in the delayed-start arm. | Drug | Delayed-start semaglutide, Immediate-start semaglutide |
Primary outcome
Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria
Time frame: At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B.
Percentage of participants who complete the assigned 26-week treatment phase while meeting all three criteria: no permanent discontinuation of prescribed adjuvant endocrine therapy; no permanent discontinuation of semaglutide; and administration of at least 21 of 26 planned weekly semaglutide injections. Endocrine therapy continuation is assessed from prescription records and self-reported intake; semaglutide adherence is assessed from electronic dosing diaries with pen reconciliation. The proportion will be reported with a 95% confidence interval.
23 secondary outcomes
Adverse events during semaglutide treatment and post-treatment follow-up
Time frame: From the first semaglutide dose to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.
Serious adverse events
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Suspected unexpected serious adverse reactions
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Adverse events of special interest
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Patient-reported symptomatic adverse events
Time frame: At protocol-specified assessments from treatment start to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.
Semaglutide dose interruptions
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Semaglutide dose reductions
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of semaglutide
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Time to permanent discontinuation of semaglutide
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of adjuvant endocrine therapy
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Completion of the semaglutide treatment phase
Time frame: At trial week 26 in Arm A and trial week 52 in Arm B.
Participant-reported acceptability of semaglutide treatment
Time frame: After treatment completion, within trial weeks 26-52 in Arm A and 52-78 in Arm B.
Participants achieving at least 5% weight loss at trial week 26
Time frame: From randomization to trial week 26 in both arms.
Percentage change in body weight from randomization to trial week 12
Time frame: Randomization baseline and trial week 12 in both arms.
Change in fat mass after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat mass percentage after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat-free mass after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fat-free mass percentage after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in skeletal muscle mass after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in EORTC QLQ-C30 Global Health Status and Quality of Life score
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in EORTC QLQ-BR45 Body Image score
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in fasting plasma glucose after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Change in total cholesterol after 26 weeks of treatment
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
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 2 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data outside the study team.
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Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
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.
Department of Oncology, Aarhus University Hospital
Aarhus N, Denmark
Signe Borgquist, MD, PhD principal investigator
Aarhus University Hospital
Sixten Harborg, MD, PhD study director
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide (Wegovy®) in people with Breast Cancer (Early Breast Cancer) and Obesity, run by Aarhus University Hospital at 2 sites 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 6 inclusion and 16 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria (time frame: At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.