TriangleNCT03901339 · STUDY IN CONTEXT
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
Draft scope assessment: unclear. Attached because the study's own record names HR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate.
CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions.
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0006
- source section id
- NCT03901339-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients. It has 5 functional scales(physical,role,emotional,cognitive, social)1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). Participant responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning.
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for GHS show a better
- population note
- The HRQOL-Evaluable Population included all participants who had an evaluable assessment at baseline and at least 1 evaluable assessment at postbaseline visits. Participants with a baseline global health status/QOL score ≥ 10 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · TTD of Pain Score as Measured by EORTC QLQ-C30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0007
- source section id
- NCT03901339-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- TTD of Pain Score as Measured by EORTC QLQ-C30
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant).
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the HRQOL-Evaluable Population with baseline pain score ≤ 90 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · TTD of Fatigue Score as Measured by EORTC QLQ-C30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0008
- source section id
- NCT03901339-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- TTD of Fatigue Score as Measured by EORTC QLQ-C30
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant).
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- trial label
- Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0000
- source section id
- NCT03901339-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
- time origin
- Up to 42.8 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0001
- source section id
- NCT03901339-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.
- time origin
- Up to 42.8 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in the ITT Population were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0002
- source section id
- NCT03901339-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment
- endpoint definition
- ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
- time origin
- Up to 42.8 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in the ITT Population with available data were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0003
- source section id
- NCT03901339-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response (DOR) by BICR and LIR Assessment
- endpoint definition
- DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate.
- time origin
- Up to 42.8 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in the ITT Population with confirmed objective response were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0004
- source section id
- NCT03901339-om-0004
- source outcome index
- 4
- endpoint
- Clinical Benefit Rate (CBR) by BICR and LIR Assessment
- endpoint definition
- CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions.
- time origin
- Up to 42.8 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in the ITT Population with available data were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0005
- source section id
- NCT03901339-om-0005
- source outcome index
- 5
- endpoint
- PFS by LIR Assessment
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
- time origin
- Up to 42.8 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in the ITT Population were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Sacituzumab Govitecan
- regimen
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Treatment of Physician's Choice (TPC)
- regimen
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- analyzed count
- 271
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03901339-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- harm key
- EG000
- source section id
- NCT03901339-ae
- event group key
- EG000
- event group label
- Sacituzumab Govitecan
- serious affected
- 74
- serious at risk
- 268
- other affected
- 264
- other at risk
- 268
- frequency threshold
- 5
- collection period
- Adverse Events and All-Cause Mortality: Up to 43.4 months
- event definition
- Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- harm key
- EG001
- source section id
- NCT03901339-ae
- event group key
- EG001
- event group label
- Treatment of Physician's Choice (TPC)
- serious affected
- 48
- serious at risk
- 249
- other affected
- 234
- other at risk
- 249
- frequency threshold
- 5
- collection period
- Adverse Events and All-Cause Mortality: Up to 43.4 months
- event definition
- Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0006
- source section id
- NCT03901339-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients. It has 5 functional scales(physical,role,emotional,cognitive, social)1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). Participant responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning.
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for GHS show a better
- population note
- The HRQOL-Evaluable Population included all participants who had an evaluable assessment at baseline and at least 1 evaluable assessment at postbaseline visits. Participants with a baseline global health status/QOL score ≥ 10 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0007
- source section id
- NCT03901339-om-0007
- source outcome index
- 7
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- TTD of Pain Score as Measured by EORTC QLQ-C30
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant).
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the HRQOL-Evaluable Population with baseline pain score ≤ 90 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-femara-ea5f0363
- nct id
- NCT03901339
- qol key
- qol-0008
- source section id
- NCT03901339-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- TTD of Fatigue Score as Measured by EORTC QLQ-C30
- measure definition
- TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant).
- time frame
- Up to 37.8 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice