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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04012918
Eligibility Criteria:
Inclusion Criteria:
1. Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy
2. Eastern Cooperative Oncology Group (ECOG) 0-2
3. Hormone receptor positive
4. No prior systemic anti-cancer therapy for advanced ER+ disease ( hormonal therapy)
5. Measurable disease defined by revised RECIST criteria (version 1.1), or bone-only disease
6. normal laboratory values
7. Postmenopausal or premenopausal with oophorectomy (medical or surgical).
Exclusion Criteria:
1. Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
2. Prior (neo) adjuvant treatment with same aromatase inhibitor type with DFI =\< 12 months from completion of treatment.
3. Known uncontrolled or symptomatic central nervous system metastases
4. Second primary malignancy
5. Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness
6. unable to swallow tablets, or malabsorption patients.
7. unwilling or unable to comply with study protocol or unable to meet the follow up.
8. patients who researchers considered were not suitable to participate.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04012918
Study Brief:
Protocol Section:
NCT04012918