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 October 03, 2024

Not yet recruiting

Keywords

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

Description

BACKGROUND: Breast cancer is the most common cancer among women worldwide, and with increasing survival rates focus on long-term adverse effects of treatment has increased. Weight gain is well documented and common occurrence for many breast cancer patients. Recently, a review reported that 50-96% of women experience weight gain during treatment. Furthermore, many patients report a progressive weight gain in the months and years after treatment and patients rarely return to their pre-diagnosis weight. Moreover, weight gain in breast cancer patients has been linked to a poor prognosis compa...

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Copenhagen, , Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0