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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT02625935
Eligibility Criteria:
Inclusion Criteria:
* Surgically resected node-negative, estrogen receptor-positive, HER2-negative early-stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
2. HER2 status will be evaluated by IHC and/or by in-situ fluorescence hybridization (0 or 1+, or 2+ will be considered negative in the absence of in-situ fluorescence hybridization).
* Postmenopausal females, which is defined as:
1. Natural Amenorrhea \> 12 months, regardless of age
2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
3. Radiological castration with amenorrhea \> 3 months, regardless of age
4. Hysterectomy and postmenopausal blood levels of FSH/LH
* Able to give informed consent
* Eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by the treating physician
* ECOG performance status of 0 or 1
Exclusion Criteria:
* Tumor specimen from core needle biopsy (CNB)
* Tumor stage T3-T4
* Non-invasive breast cancer (e.g., Paget's disease, DCIS)
* Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
* Tumors that are estrogen receptor (ER) negative or HER2-positive
* Have metastatic disease
* Have received another genomic test for prognosis of early breast cancer (i.e., Oncotype Dx, Mammaprint, or BCI)
* Unable to give informed consent
* Unable to complete patient reported outcome surveys
* Have contraindications for adjuvant chemotherapy, as determined by the treating physician
o Age, performance status, significant comorbidities, etc.
* ECOG performance status \> 1
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT02625935
Study Brief:
Protocol Section:
NCT02625935