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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT02767661
Eligibility Criteria:
Inclusion Criteria:
* Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy
* Confirmed diagnosis of ER positive/Her2-negative breast cancer
* No prior systemic anti-cancer therapy for locoregionally recurrent or metastatic disease
* Any menopausal status, but premenopausal or perimenopausal patients are required to receive LHRHa treatment
* Measurable disease defined by RECIST version 1.1, or bone-only disease
* Eastern Cooperative Oncology Group (ECOG) 0-2, and life expectancy ≥ 3 months
* Adequate organ and marrow function
* Resolution of all toxic effects of prior therapy or surgical procedures
Exclusion Criteria:
* Patients who have progressed within 2 years of adjuvant endocrine therapy
* Patients who have not received prior endocrine therapy and are eligible to receive fulvestrant as initial therapy
* Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
* Known uncontrolled or symptomatic central nervous system metastases
* Diagnosis of any other malignancy within 3 years prior to randomization (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ)
* Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02767661
Study Brief:
Protocol Section:
NCT02767661