{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","groupDescription":"This analysis includes only premenopausal participants.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.","pValue":"0.009","paramType":"Hazard Ratio (HR)","paramValue":"0.58","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.81","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.37","estimateComment":"To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.","groupDescription":"This analysis includes only postmenopausal participants.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.70","paramType":"Hazard Ratio (HR)","paramValue":"1.05","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"96.1"},{"groupId":"OG001","value":"92.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"829"},{"groupId":"OG001","value":"826"}],"units":"Participants"}],"title":"Premenopausal participants"},{"categories":[{"measurements":[{"groupId":"OG000","value":"94.4"},{"groupId":"OG001","value":"94.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1658"},{"groupId":"OG001","value":"1671"}],"units":"Participants"}],"title":"Postmenopausal participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2487"},{"groupId":"OG001","value":"2497"}],"units":"Participants"}],"description":"Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence or death due to any cause. Participants last known to be alive who have not experienced distant recurrence are censored at their last contact date. This outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Kaplan-Meier estimates were calculated for the 5-year DRFS rate.\n\nDue to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status. The NCI and the data and safety monitoring committee recommended early reporting of the data. Due to subsequent data collection and data cleaning, the population of eligible and evaluable participants differs slightly between the reporting of this outcome and the Participant Flow section.","groups":[{"description":"Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Chemo and Endocrine Therapy"},{"description":"Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Endocrine Therapy Alone"}],"paramType":"NUMBER","populationDescription":"Eligible and evaluable participants","reportingStatus":"POSTED","timeFrame":"5 years after randomization","title":"Distant Relapse-Free Survival (DRFS)","type":"POST_HOC","unitOfMeasure":"percentage of participants"}