Investigating the impact of HER2 receptor signaling on brown fat activity in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.