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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT03238703
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent
* A diagnosis of invasive breast cancer, with or without an in situ component, that is:
* Originally identified by screening mammography
* Characterized by standard diagnostic mammography +/- breast ultrasound
* Clinically node negative
* Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=\< 2 cm, node negative, unifocal invasive)
* Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each \> 5/8
* Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
* ki-67 proliferation scored, \< 20%
* Clinical Nottingham grade 1 or 2
* Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk
* Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range
* Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM)
* Willing to undergo routine surveillance with breast ultrasound and/or mammography
Exclusion Criteria:
* Known contraindication to aromatase inhibitor or SERM therapy
* Pregnant at time of or within prior year of diagnosis
* Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla
* Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
* Prior use of aromatase inhibitor therapy apart from assisted reproduction
* Prior use of SERM
* Unmanaged/uncontrolled mental health disorder
* Life expectancy \< 6 months (m) for any cause
* Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive
* DCIS with focal invasion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT03238703
Study Brief:
Protocol Section:
NCT03238703