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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT01698918
Eligibility Criteria:
Inclusion Criteria:
* Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
* Histological or cytological confirmation of ER+/ HER2- breast cancer
* Postmenopausal women
* No prior treatment for metastatic breast cancer
Exclusion Criteria:
* Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
* Patients who had received prior hormonal or any other systemic therapy for metastatic breast cancer. Patients might have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
* Previous treatment with mTOR inhibitors.
* Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
Other protocol-defined inclusion/exclusion criteria might apply
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01698918
Study Brief:
Protocol Section:
NCT01698918