Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01610284 | Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor | PHASE3 | COMPLETED | 1,147 | — | — | Aug 7, 2012 | Apr 19, 2019 | Aug 25, 2020 | 268 | United States, Argentina +27 |
| NCT02404844 | Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer | PHASE2 | COMPLETED | 48 | — | — | Dec 1, 2014 | Oct 19, 2017 | Apr 20, 2018 | 1 | Germany |
| NCT01629615 | A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer | PHASE2 | COMPLETED | 50 | — | — | Jun 1, 2012 | Oct 1, 2015 | Oct 28, 2020 | 7 | United States, Spain |
| NCT01572727 | A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation | PHASE2 | COMPLETED | 416 | — | — | Aug 1, 2012 | Jun 1, 2015 | Mar 9, 2017 | 112 | United States, Australia +20 |
| NCT01068483 | Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients | PHASE1 | COMPLETED | 107 | — | — | Nov 1, 2008 | Aug 1, 2012 | Dec 8, 2020 | 5 | United States, Canada +2 |
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment
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.
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| BKM120 100mg + Fulvestrant | EXPERIMENTAL | BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. |
| Placebo + Fulvestrant | PLACEBO_COMPARATOR | BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol. |
| BKM120 + Tamoxifen | EXPERIMENTAL | BKM120 (Buparlisib): 100 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle Tamoxifen: 20 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle |
| BKM120 | EXPERIMENTAL | - |
| BKM120 and paclitaxel | EXPERIMENTAL | Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel. |
| Placebo and paclitaxel | ACTIVE_COMPARATOR | Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel. |
| Name | Type | Description |
|---|---|---|
| Fulvestrant | DRUG | Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter) |
| BKM120 | DRUG | BKM120 100 mg once daily |
| BKM120 matching placebo | DRUG | BKM120 matching placebo, once daily |
| Tamoxifen | DRUG | daily oral |
| Paclitaxel | DRUG | intravenous paclitaxel 80 mg/m2 per week given until progression |
Key Inclusion Criteria: * Locally advanced or metastatic breast cancer * HER2-negative and hormone receptor-positive status (common breast cancer classification tests) * Postmenopausal woman * A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K ...