Actively Recruiting
The Effects of HER2 Receptor Signaling on Human Brown Fat Activity
Led by Rigshospitalet, Denmark · Updated on 2024-11-19
30
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this observational study is to investigate the significance of the HER2 receptor for brown fat activity in humans. Our preliminary data clearly demonstrates that the ErbB signaling pathway, which includes the HER2 receptor, strongly promotes development and function of cultured human BAT cells. The HER2 receptor is a part of the ErbB signaling pathway, and antibodies against thee HER2 receptor are a part of the standard treatment for HER2-positive breast cancer. Therefore, the hypothesis is that the activity of brown fat will be reduced in patients treated with HER2 blocking antibody compared to patients who are not treated with HER2 blocking antibody. The present study simply takes advantage of the treatment protocol to explore the contribution of the HER2 receptor in the development of brown adipose tissue in humans. Participants will complete two testing days, one before and one after their treatment period of approx. one year. On the testing days, identification of brown fat activity will be performed using cooling and infrared thermography. In addition, resting metabolic rate and a glucose tolerance test will be performed. Since presence of active brown adipose tissue in humans is inversely related to obesity, total and visceral fat mass, plasma glucose levels, presence of cardiovascular disease and diabetes status, it is of great importance to investigate the molecular mechanisms for development of brown fat tissue and may lead to discovery of novel strategies to counteract obesity and obesity related disorders.
CONDITIONS
Official Title
The Effects of HER2 Receptor Signaling on Human Brown Fat Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age over 18 years
- Histologically confirmed breast cancer
- No prior neoadjuvant treatment
- Estrogen receptor positive (>1%)
- Presence of cold activated brown fat shown by a temperature increase greater than 16C after cooling
- For HER2 positive group: HER2 positive breast cancer defined by ASCO/CAP criteria
- Scheduled to receive 17 series of trastuzumab and endocrine treatment (HER2 positive group)
- For control group: HER2 negative breast cancer defined by ASCO/CAP criteria
- Scheduled to receive adjuvant chemotherapy and endocrine treatment (HER2 negative group)
You will not qualify if you...
- Any other cancer with clinical activity within the last 2 years, except carcinoma in situ and radically operated localized squamous skin cancer
- Metastatic breast cancer
- Metabolic diseases such as diabetes (exceptions if well treated and approved by a medical doctor)
- Regular use of prednisolone (except use related to chemotherapy)
- Pregnancy
- Untreated or uncontrolled hypertension with systolic BP > 155 and diastolic BP > 95
- Clinically significant ventricular or atrial arrhythmia
- Untreated coronary artery disease or angina pectoris
- Symptomatic heart failure (NYHA class 2 or higher)
- Known cold urticaria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
T
Tora Ida Henriksen, MSc., Ph.D.
CONTACT
C
Christina Yfanti, MSc, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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