Investigating the impact of HER2 receptor signaling on brown fat activity in breast cancer patients
The Effects of HER2 Receptor Signaling on Human Brown Fat Activity: A 1-year Prospective Cohort Study in Trastuzumab-treated Breast Cancer Patients Versus HER2 Negative Controls
This study is testing how the HER2 receptor affects brown fat activity in breast cancer patients to see if it plays a role in weight management after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06222957 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of the HER2 receptor in the activity of brown adipose tissue (BAT) among breast cancer patients. It will compare the BAT activity in HER2-positive patients receiving trastuzumab treatment to that of HER2-negative patients. Participants will undergo testing on two occasions, once before and once after approximately one year of treatment. The study seeks to understand how HER2 receptor signaling affects brown fat function, which may have implications for weight management in breast cancer survivors.
Who should consider this trial
Good fit: Ideal candidates include female patients over 18 years old with histologically confirmed HER2-positive or HER2-negative breast cancer who are scheduled to receive adjuvant chemotherapy.
Not a fit: Patients with other active cancers or those who have received prior neoadjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing weight gain and metabolic health in breast cancer patients undergoing HER2-targeted therapies.
How similar studies have performed: While the specific focus on HER2 receptor signaling and brown fat activity is novel, related studies have shown the importance of brown fat in metabolic health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
General inclusion criteria: * Female * Age \> 18 years * Histologically confirmed breast cancer * No prior neoadjuvant treatment * Estrogen receptor positive (\>1%) * Presence of cold activated brown fat as evidenced by a change in Δtemp. of \>1°C (post cooling - precooling temperature). HER2 positive group: HER2-positive (HER2+) and Estrogen receptor-positive (ER+) breast cancer patients (N = 15): * HER2 positive breast cancer as defined by ASCO/CAP criteria * Scheduled to receive adjuvant chemotherapy, a total of 17 series of trastuzumab and endocrine treatment Control group: HER2-negative breast cancer patients (HER2-) and Estrogen receptor-positive (ER+) breast cancer patients (N = 15): * HER2 negative breast cancer as defined by ASCO/CAP criteria * Scheduled to receive adjuvant chemotherapy and endocrine treatment Exclusion Criteria: * Any other cancer (excluding carcinoma in situ and radically operated localised squamous skin cancer) with clinical activity within the last 2 years * Metastatic breast cancer * Metabolic diseases such as diabetes (exceptions can be made if the disease is well treated, assessed by the clinically responsible medical doctor (see section 18)) * Regular use of prednisolone - use in relation to chemotherapy only is ok * Pregnancy * Untreated or dysregulated hypertension defined as outpatient clinic systolic BP \> 155 and diastolic BP \> 95 * Clinically significant ventricular or atrial arrhythmia * Untreated coronary artery disease or angina pectoris * Symptomatic heart failure (NYHA ≥ 2) * Known cold urticaria
Where this trial is running
Copenhagen
- Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Søren Nielsen, MSc., Ph.D. — Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark
- Study coordinator: Tora Ida Henriksen, MSc., Ph.D.
- Email: tora.ida.henriksen@regionh.dk
- Phone: +45 35 45 73 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.