Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Laboratory Manual.\nParticipants were analysed based on the current American Joint Committee on Cancer (AJCC) staging system as follows:
Modified Pre-operative Endocrine Prognostic Index (mPEPI) score is an investigational prognostic tool used to predict the risk of breast cancer recurrence.\nIt will be derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nThe factors include pathologic tumor size, and lymph node status and Ki67 expression in the surgical specimen.\nTotal mPEPI score (mPEPI_T) per participant is the sum of mPEPI score of each factor.
mPEPI score of 0 indicates Pathological tumor size T1-T2, no lymph nodes and Ki67 level of 0%-2.7%, 1 indicates: Ki67 level >2.7%-7.3%, 2 indicates Ki67 level >19.7%-53.1% and 3 indicates: tumor sizeT3-T4, presence of lymph nodes and Ki67 level >53.1%.
"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description","value":"Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% \u00d7 (1 - geometric mean ratio between Ki-67 at C1D15 and Ki-67 at baseline)."},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description","value":"Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Laboratory Manual.\nParticipants were analysed based on the current American Joint Committee on Cancer (AJCC) staging system as follows:
Modified Pre-operative Endocrine Prognostic Index (mPEPI) score is an investigational prognostic tool used to predict the risk of breast cancer recurrence.\nIt will be derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nThe factors include pathologic tumor size, and lymph node status and Ki67 expression in the surgical specimen.\nTotal mPEPI score (mPEPI_T) per participant is the sum of mPEPI score of each factor.
mPEPI score of 0 indicates Pathological tumor size T1-T2, no lymph nodes and Ki67 level of 0%-2.7%, 1 indicates: Ki67 level >2.7%-7.3%, 2 indicates Ki67 level >19.7%-53.1% and 3 indicates: tumor sizeT3-T4, presence of lymph nodes and Ki67 level >53.1%.
"},{"op":"replace","path":"/resultsSection/adverseEventsModule/timeFrame","value":"Adverse Events: From first study drug administration up to approximately 6.5 months. All-cause mortality: From randomization up to approximately 6.5 months."},{"op":"replace","path":"/resultsSection/adverseEventsModule/description","value":"Adverse events were collected for the Safety Analysis Set consisting of all enrolled participants who received at least 1 dose of study intervention.\nFor All-Cause Mortality, events were collected from the Full Analysis Set, which included all the enrolled participants who were randomized."},{"op":"remove","path":"/annotationSection"}],"provenance":{"from_snapshot_hash":"946531f46c65ff4a2af47e4632618a073871ecbd6c491b638223f6472c1ad733","materiality_event_hash":"d416cde94cae8e882100d7e0a0f18312a1fcb1ca16298641cd6d0fa021356c4f","patch_hash":"098370f38adbb892660901329a3b4a4524bf708773debab65bef32ebac5830e1","patch_raw_hash":"149835ac8d8943939533cdc95225d79b51dc3d414cac7db6595585c2572d7205","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT05549505/history/9?patchToVersion=10","to_snapshot_hash":null},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT05549505","nct_id":"NCT05549505"},"versions":{"from_version":9,"submitted_date":"2025-08-12","to_version":10}}