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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT02646735
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent document on file;
* Age over 60 years;
* Age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
* Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
* ER + and/or PgR +;
* Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
* WHO performance status 0, 1 or 2;
* Patients with life expectancy of more than 3 months.
Exclusion Criteria:
* Presence of life-threatening metastatic visceral disease;
* Previous systemic chemotherapy for advanced breast cancer;
* Received systemic endocrine therapy for advanced disease;
* Extensive radiation therapy within the last 4 weeks ;
* Platelets \< 100\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
* Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
* History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02646735
Study Brief:
Protocol Section:
NCT02646735