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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT02820961
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal female patients
* Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator
* Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have acceptable, applicable laboratory requirements
* Patients may have a history of brain metastasis provided certain protocol criteria are met
* Able to understand and give written informed consent and comply with study procedures
Exclusion Criteria:
* Rapidly progressive or life-threatening metastases
* Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes
* History of significant GI surgery as determined by Investigator
* A medical condition that precludes adequate study treatment or increases patient risk
* Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02820961
Study Brief:
Protocol Section:
NCT02820961