{"analyses":[{"ciLowerLimit":"0.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.05","groupDescription":"This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.35","paramType":"Hazard Ratio (HR)","paramValue":"1.02","statisticalComment":"A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\\*recurrence score interaction term.","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"1.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.54","groupDescription":"This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.008","paramType":"Hazard Ratio (HR)","paramValue":"1.71","statisticalComment":"A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\\*menopausal status interaction term.","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.83","estimateComment":"To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.","groupDescription":"This analysis includes only premenopausal participants.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.002","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.26","estimateComment":"To compare the Chemo and Endocrine Therapy arm to 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":"0.89","paramType":"Hazard Ratio (HR)","paramValue":"1.02","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.9"},{"groupId":"OG001","value":"89.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"829"},{"groupId":"OG001","value":"826"}],"units":"Participants"}],"title":"Premenopausal"},{"categories":[{"measurements":[{"groupId":"OG000","value":"91.3"},{"groupId":"OG001","value":"91.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1658"},{"groupId":"OG001","value":"1671"}],"units":"Participants"}],"title":"Postmenopausal"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2487"},{"groupId":"OG001","value":"2497"}],"units":"Participants"}],"description":"From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate.\n\nDue to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events 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":"For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.","reportingStatus":"POSTED","timeFrame":"5 years after randomization","title":"Invasive Disease-Free Survival (IDFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}