Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06222957
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06222957
Study Brief:
Protocol Section:
NCT06222957