{"analyses":[{"ciLowerLimit":"0.514","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.799","estimateComment":"Hazard ratio was calculated based on stratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.641","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95 % confidence interval (CI) could not be calculated due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"21.3","upperLimit":"NA","value":"24.9"},{"groupId":"OG001","lowerLimit":"12.6","upperLimit":"18.7","value":"16.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"328"}],"units":"Participants"}],"description":"PFS: time from randomization to the first documented disease progression (PD) (as assessed by investigator per RECIST 1.1) or death from any cause, whichever occurred first. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameter recorded since the treatment started or the appearance of 1 or more new lesions. Participants without documentation of PD/ death at the time of analysis, were censored at date of last tumor assessment with an overall response of complete response (CR), partial response (PR), stable disease (SD), non-CR/non-PD or no evidence of disease (NED). CR: disappearance of all target lesions; PR: \\>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.","id":"OG000","title":"Tucatinib + Trastuzumab + Pertuzumab"},{"description":"Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.","id":"OG001","title":"Placebo + Trastuzumab + Pertuzumab"}],"paramType":"MEDIAN","populationDescription":"ITT analysis set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)","title":"Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1","type":"PRIMARY","unitOfMeasure":"Months"}