Statement: the primary trial does not investigate the effects of its intervention on patient tpCR.
Primary_evidence: Outcome Measurement:    Progression Free Survival (PFS)   PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.   Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) Results 1:    Arm/Group Title: Ipatasertib and Paclitaxel   Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.   Overall Number of Participants Analyzed: 62   Median (90% Confidence Interval)   Unit of Measure: Months  6.18        (4.57 to 7.33) Results 2:    Arm/Group Title: Placebo and Paclitaxel   Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.   Overall Number of Participants Analyzed: 62   Median (90% Confidence Interval)   Unit of Measure: Months  4.93        (3.58 to 5.36)