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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT02214004
Eligibility Criteria:
Inclusion Criteria:
* Invasive cancer (clinical stage IB-IIIC)
* Measurable tumor larger than 1cm
* ECOG status 0 or 1
* Postmenopausal women
* Age ≥55 years and amenorrhea
* Age \<55 years and amenorrhea for ≥12 months with FSH \>30 mIU/ml
* HER2 positive tumor
* 3 positive on IHC
* 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
* Estrogen receptor positive tumor
* Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
* Eligible cardiac function
* Normal heard evaluated by ECG
* Consider clinically non-significant arrythmia and ischemic change as normal
* LVEF ≥ 55% measured by ECHO or MUGA scan
Exclusion Criteria:
* Inflammatory breast cancer
* Bilateral breast cancer
* Patients with previous breast cancer history
* Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
* Patients having uncontrolled heart problems
* Ischemic heart disease within 6 months
* Congestive heart failure more than NYHA class II
* Unstable angina
* Clinically significant pericarditis
* Amyloid heart disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02214004
Study Brief:
Protocol Section:
NCT02214004