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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01633060
Eligibility Criteria:
Key inclusion criteria
* Female patients age 18 years or older
* Histologically and/or cytologically confirmed diagnosis of breast cancer
* Radiologic evidence of inoperable locally advanced or metastatic breast cancer
* Adequate tumor tissue for the analysis of PI3K-related biomarkers
* Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
* Postmenopausal women
* Prior treatment with aromatase inhibitors
* Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
* Adequate bone marrow and organ function
* ECOG performance status ≤ 2
Key exclusion criteria
* Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant
* More than one chemotherapy line for metastatic disease
* Hypersensitivity to any of the excipients of buparlisib or fulvestrant
* Symptomatic central nervous system metastases
* Concurrent malignancy or malignancy within 3 years of study enrollment
* Certain drugs or radiation within 2-4 weeks of enrollment
* Increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent
* Certain scores on an anxiety and depression mood questionnaire given at screening
* Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
* Active cardiac disease or a history of cardiac dysfunction
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01633060
Study Brief:
Protocol Section:
NCT01633060