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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT01790932
Eligibility Criteria:
Inclusion Criteria:
* Pathologically and radiologically confirmed metastatic triple negative breast cancer
* Up to two prior lines of chemotherapy for metastatic breast cancer
* Availability of a representative tumor specimen
* At least one measurable lesion
Exclusion Criteria:
* Have received previous treatment with PI3K inhibitors
* Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable)
* Concurrent malignancy or has a malignancy within 3 years of study enrollment
* Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety
* Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study
* Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy
* Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery
* Poorly controlled diabetes mellitus
* History of cardiac dysfunction
* Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
* Receiving chronic treatment with steroids or another immunosuppressive agent
* Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study
* History of non-compliance to a medical regimen
* Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)
* Known history of human immunodeficiency virus (HIV)
* Pregnant or breastfeeding
* Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01790932
Study Brief:
Protocol Section:
NCT01790932