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ipatasertib plus paclitaxel (n=146) vs. paclitaxel (n=76)
randomized controlled trial
ipatasertib plus paclitaxel
ipatasertib: PO 400mg daily on days 1-21 / paclitaxel: IV 80mg/m² on days 1, 8 and 15
placebo plus paclitaxel
paclitaxel: IV 80mg/m² on days 1, 8 and 15
la/mBC - HR positive - L1 - PIK3CA mutant
double blind
180 sites in worldwide (Asia, Australia, Europe, North America, South-Africa and South America)
P3 / PFS at 2-sided at 5% / OS with hierachically testing at 2-sided at 5%
Adding ipatasertib to paclitaxel did not improve PFS in patients with hr-positive and HER2-negative breast cancer (with PIK3CA altered)
capivasertib plus paclitaxel (n=54) vs. paclitaxel (n=56)
randomized controlled trial
capivasertib plus paclitaxel
capivasertib: PO twice daily, each week paclitaxel was received, 2 intermittent dosing schedules of schedule 1 (2 days on then 5 days off treatment, starting at a dose of 560mg) and schedule 2 (4 days on then 3 days off treatment, starting at a dose of 36mg) / paclitaxel: 90 mg/m2 in 4-weekly cycles
placebo plus paclitaxel
paclitaxel: 90 mg/m2 in 4-weekly cycles
la/mBC - HR-positive - 1st line (L1)
double blind
Asia, Canada, Europe, South America
P2 / PFS at 1-sided at 10%
Adding capivasertib to weekly paclitaxel seemed to not prolong PFS in the overall population or PIK3CAþ sub-population of ERþ/HER2 advanced/metastatic breast cancer patients.
capivasertib plus paclitaxel (n=70) vs. Standard of Care (SoC) (n=70)
randomized controlled trial
capiversatib plus paclitaxel
Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle / Capivasertib 400mg orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle.
placebo plus paclitaxel
Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle / Placebo orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle.
If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of AE, capiversatib or placebo could be reduced or interrupted.
mBC - TNBC - L1 - all population
Patients with brain metastases were excluded unless they had completed treatment, were asymptomatic, and had been stable for 3 months. Patients with previous treatment with PI3K, AKT, or mammalian target of rapamycin inhibitors were excluded. // The difference between groups was that in the control groups, there was more patient with visceral disease.
double-blind
42 academic medical centers (UK, South Korea, France, Hungary, Romania, and Georgia)
P2 / for PFS significance level at 10% (1-sided), an interim efficacy analysis not taken into account for the alpha because this IA will not form the basis of any stop or acceleration decisionsExploratory results, no SAP
this study was an exploratory analysis
ipatasertib plus paclitaxel (n=62) vs. Standard of Care (SoC) (n=62)
randomized controlled trial
ipatasertib plus paclitaxel
ipatasertib: 400mg/day PO on days1-21 of each 28-day cycle / paclitaxel: 80mg/m² on days 1, 8 and 15 of each 28-day cycle
placebo plus paclitaxel
placebo matching ipatasertib: PO on days1-21 of each 28-day cycle / paclitaxel: 80mg/m² on days 1, 8 and 15 of each 28-day cycle
mBC - TNBC - L1 - all population
Exclusion criteria: patients with known brain or spinal cord metastasis.
double-blind
44 hospitals in South Korea, USA, France, Spain, Taiwan, SIngapore, Italy and Belgium
P2 / exploratory results, no SAP
capivasertib plus paclitaxel (n=17) vs. Standard of Care (SoC) (n=11)
randomized controlled trial
capiversatib plus paclitaxel
Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle / Capivasertib 400mg orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle.
placebo plus paclitaxel
Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle / Placebo orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle.
If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of AE, capiversatib or placebo could be reduced or interrupted.
mBC - Triple negative (TNBC) - 1st Line (L1)
Patients with brain metastases were excluded unless they had completed treatment, were asymptomatic, and had been stable for 3 months. Patients with previous treatment with PI3K, AKT, or mammalian target of rapamycin inhibitors were excluded. // The difference between groups was that in the control groups, there was more patient with visceral disease.
double-blind
42 academic medical centers (UK, South Korea, France, Hungary, Romania, and Georgia)
P2 / for PFS significance level at 10% (1-sided), an interim efficacy analysis not taken into account for the alpha because this IA will not form the basis of any stop or acceleration decisionsExploratory results no SAP
this study was an exploratory analysis
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