This study will examine the impact of a prognostic gene profiling test EndoPredict® – on adjuvant treatment recommendations in early breast cancer patients, who are ER positive seen at Westmead BCI, VCCC or St Vincent's Hospital.
- Conditions
- Early Breast Cancer with ER/PR positive and HER2 NegativeCancer - Breast
- Registration Number
- ACTRN12618001284257
- Lead Sponsor
- Westmead Breast cancer Institute, Westmead Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 200
Females (18 – 80 years)
ECOG Performance Status 0-1
Resected estrogen-receptor-positive, HER2-negative, early stage invasive breast cancer (T1-T2N0-1M0)
Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells of any intensity will be considered positive.
HER2 status will be evaluated by in situ hybridisation using current ASCOCAP guidelines for scoring (HER2:CEP17 ratio >2 will be considered positive
Tumor size T3-T4
Non-invasive breast cancer (e.g., Paget's disease, DCIS)
Greater than 3 involved axillary nodes
Tumors that are estrogen-receptor negative or HER2 positive
Distant metastatic disease
Unable to give informed consent Significant co-morbidities or contraindications for adjuvant chemotherapy
ECOG Performance Status 2-4
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method