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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01009918
Eligibility Criteria:
INCLUSION CRITERIA
* Males and Females ≥ 18 years old diagnosed with HER2 positive breast cancer
* Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.
* Left Ventricular Ejection Fraction (LVEF) ≥ 50% by MUGA scan or echocardiogram
* Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.
* Sitting systolic blood pressure of \> 90 mm Hg
* Pulse ≥ 60 beats/minute
* Not pregnant or breastfeeding
* Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study
* Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents
* Able to swallow capsules
EXCLUSION CRITERIA:
* Patients with metastatic disease
* Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen
* Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin
* Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction
* Known allergy to either ACE inhibitors or β-blockers
* History of bronchial asthma or related bronchospastic conditions
* Hereditary or idiopathic angioedema
* History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings
* This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01009918
Study Brief:
Protocol Section:
NCT01009918