The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.
The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).
Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7
","measure":"Patient Reported Outcomes (Global Health Status)","timeFrame":"The questionnaire was filled by the patients at screening and post adjuvant therapy."}]},{"op":"remove","path":"/protocolSection/contactsLocationsModule/centralContacts"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/0/status"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/0/contacts"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/0/state","value":"Barcelona"},{"op":"remove","path":"/annotationSection"},{"op":"replace","path":"/hasResults","value":true},{"op":"add","path":"/resultsSection","value":{"adverseEventsModule":{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):
Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):
Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):
Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):
The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.
The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).
Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7
","dispersionType":"Full Range","groups":[{"description":"Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.
The assessment time period is at screening
","id":"OG000","title":"Patients Who Underwent Surgery (Assessment at Screening)"},{"description":"Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.
The assessment time period is after adjuvant therapy
","id":"OG001","title":"Patients Who Underwent Surgery (Assessment After Adjuvant Therapy)"},{"description":"Of the treatment population, those patients with omission of surgery post neoadjuvant therapy.
The assessment time period is at screening
","id":"OG002","title":"Patients With Omission of Surgery (Assessment at Screening)"},{"description":"Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.
The assessment time period is after adjuvant therapy
","id":"OG003","title":"Patients With Omission of Surgery (Assessment After Adjuvant Therapy)"}],"paramType":"MEDIAN","populationDescription":"Out of the treatment population, 3 patients underwent surgery post neoadjuvant therapy (standard therapy) and 2 patients did not undergo surgery (investigative therapy).\nAll the patients of both the groups completed the patient reported outcomes questionaire at screening. 1 patient from the patient group that underwent surgery did not complete the questionnaire after adjuvant therapy.","reportingStatus":"POSTED","timeFrame":"The questionnaire was filled by the patients at screening and post adjuvant therapy.","title":"Patient Reported Outcomes (Global Health Status)","type":"SECONDARY","unitOfMeasure":"score on a scale"}]},"participantFlowModule":{"groups":[{"description":"Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):
Out of 20 patients screened, 13 patients did not fulfill the study criteria (PAM50 subtype other than HER2-Enriched, ERBB2 high, liver metastasis, multicentric tumor).
Finally only 5 patients that fulfilled all eligibility criteria and signed the ICF were included
","recruitmentDetails":"Overall, 20 patients were screened for the study in a single study centre (clinical setting) over the duration of 18 months.\nA total of 5 patients were finally selected for the study treatment after meeting all the inclusion criteria and signing the ICF"}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2019-10-17","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":4292401,"typeAbbrev":"Prot_SAP","uploadDate":"2025-09-03T04:05"}]}}}],"provenance":{"from_snapshot_hash":"5e985270d681649633bafe0f41747fc0682a970faef0b062f57856ef13c7124e","materiality_event_hash":"1fd364e26df968636c88d5e3ef4cbec41a16a26544b5564d1d06c3dcdb7fbe16","patch_hash":"9c1dfc8c1bd85d5723205c9461e8f3a6553c816ba10f133c26b6838bd95f7c34","patch_raw_hash":"a68b9ecbe4dbb00b60fceea292ad569cdd000698143e0c0351e550c1829fc245","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT04578106/history/3?patchToVersion=4","to_snapshot_hash":null},"review_question":"Does the public registry record give a specific explanation for the stopped or terminal status?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT04578106","nct_id":"NCT04578106"},"versions":{"from_version":3,"submitted_date":"2026-01-02","to_version":4}}