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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03596658
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-70 years.
* Confirmation of ER positive; HER2 negative Advanced breast cancer
* Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
* Receipt of ≤2 lines of prior chemotherapy for advanced disease.
* Any menopausal status.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
Exclusion Criteria:
* Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
* Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
* uncontrolled central nervous system metastatic disease.
* Any evidence of severe or uncontrolled systemic diseases.
* Inadequate bone marrow reserve or organ function.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03596658
Study Brief:
Protocol Section:
NCT03596658