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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01974856
Eligibility Criteria:
Inclusion Criteria:
* Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
* Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
* HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
* Postmenopausal women defined as:
* Natural Amenorrhea \> 12 months, regardless of age
* Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
* Radiological castration with amenorrhea \> 3 months, regardless of age
* Hysterectomy and postmenopausal blood levels
* Able to give consent
* Eligible for treatment of breast cancer with adjuvant chemotherapy
* ECOG performance status of 0 or 1
Exclusion Criteria:
* Tumor size 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 negative or HER2 positive
* Have metastatic disease
* Unable to give informed consent
* Unable to complete patient reported outcome surveys
* Have contraindications for adjuvant chemotherapy
* Age, performance status, significant comorbidities
* ECOG performance status \> 1
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01974856
Study Brief:
Protocol Section:
NCT01974856