A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01629615|
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : October 28, 2020
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: BKM120||Phase 2|
This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory study of single agent BKM120 in the treatment of metastatic triple negative breast cancer patients.
Patients will first undergo screening, tumor measurement and collection of available tumor block from the primary tumor and/or a metastatic site. Available tumor block is required in all patients per inclusion criteria. Analysis of this tumor block will be used for correlation of predictive markers and clinical response in order to define potential subpopulation that benefit from BKM120.
Following confirmation of eligibility criteria, subjects will be enrolled. BKM120 will then be administered in a 100mg dose, orally, once daily, in a continuous schedule. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations.
Treatment with BKM120 will continue until disease progression, unacceptable toxicity that precludes any further treatment, and/or discontinuation of the treatment by investigator or patient decision.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
- Rate of Clinical Benefit [ Time Frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months. ]Clinical benefit rate (CBR) was defined as the percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is the complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.
- Progression-free Survival [ Time Frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for PFS on average approximately 2 months. ]Progression-free survival (PFS) based on the Kaplan-Meier (KM) method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. Per RECIST 1.1 criteria: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
- Overall Survival [ Time Frame: 2 years ]Overall survival was defined as the time from date of study enrollment until death from any cause.
- Frequency and Severity of Adverse Events [ Time Frame: Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants were followed for AEs on average approximately 2 months. ]Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per Common Toxicity Criteria for Adverse Events (CTCAE) version 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629615
|United States, Massachusetts|
|Dana-Farber at Faulkner Hospital|
|Boston, Massachusetts, United States, 02130|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Hospital Universitario Vall d´Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Hospital Clínico Universitario de Valencia|
|Valencia, Spain, 46010|
|Study Chair:||Jose Baselga, MD||Massachusetts General Hospital|
|Study Chair:||Eric Winer, MD||Dana-Farber Cancer Institute|
|Principal Investigator:||Jordi Rodon, MD||Hospital Universitario Vall d´Hebron|