Search / Trial NCT06222957

The Effects of HER2 Receptor Signaling on Human Brown Fat Activity

Launched by RIGSHOSPITALET, DENMARK · Jan 24, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Her2 Receptor Her2 Receptor Positive Brown Adipose Tissue Human Brown Fat Trastuzumab Cooling Infrared Thermography

ClinConnect Summary

This clinical trial is studying how a specific protein called the HER2 receptor affects the activity of brown fat in women with breast cancer. Brown fat is a type of fat in our bodies that helps burn calories and can be important for managing weight and health. The researchers want to see if blocking the HER2 receptor with standard treatments, which is common for HER2-positive breast cancer, reduces the activity of brown fat compared to those who don’t receive this treatment.

To participate in this study, women must be over 18 years old, have confirmed breast cancer that is estrogen receptor positive, and show a specific response in their brown fat when cooled. Participants will take part in two testing days: one before starting treatment and one about a year later. During these visits, they will undergo tests to see how their brown fat is working, as well as their metabolism and how their body handles glucose (a type of sugar). This research could help scientists understand more about how to tackle obesity and related health issues in the future.

Gender

FEMALE

Eligibility 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

Trial Officials

Søren Nielsen, MSc., Ph.D.

Principal Investigator

Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Copenhagen, , Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0