TriangleNCT01631552 · STUDY IN CONTEXT
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. 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
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.
Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- trial label
- Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0000
- source section id
- NCT01631552-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
- endpoint definition
- Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.
- time origin
- First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG * OSP: All participants who received at least 1 dose of SG
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0001
- source section id
- NCT01631552-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death
- endpoint definition
- Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
- time origin
- First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG * OSP: All participants who received at least 1 dose of SG
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0002
- source section id
- NCT01631552-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events
- endpoint definition
- Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
- time origin
- First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG * OSP: All participants who received at least 1 dose of SG
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0003
- source section id
- NCT01631552-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate (ORR) by Independent Central Review (ICR)
- endpoint definition
- ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
- time origin
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg.
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0004
- source section id
- NCT01631552-om-0004
- source outcome index
- 4
- endpoint
- Objective Response Rate by Local Assessment
- endpoint definition
- ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
- time origin
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0005
- source section id
- NCT01631552-om-0005
- source outcome index
- 5
- endpoint
- Duration of Response by ICR
- endpoint definition
- Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
- time origin
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
- 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-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0000
- arm key
- OG000
- arm label
- TNBC Target Population
- regimen
- Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
- analyzed count
- 108
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0000
- arm key
- OG001
- arm label
- HR+/HER2- mBC Population
- regimen
- Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0000
- arm key
- OG002
- arm label
- mUC Population
- regimen
- Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Overall Safety Population (OSP)
- regimen
- Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0001
- arm key
- OG000
- arm label
- TNBC Target Population
- regimen
- Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
- analyzed count
- 108
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0001
- arm key
- OG001
- arm label
- HR+/HER2- mBC Population
- regimen
- Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0001
- arm key
- OG002
- arm label
- mUC Population
- regimen
- Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Overall Safety Population (OSP)
- regimen
- Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0002
- arm key
- OG000
- arm label
- TNBC Target Population
- regimen
- Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
- analyzed count
- 108
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0002
- arm key
- OG001
- arm label
- HR+/HER2- mBC Population
- regimen
- Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0002
- arm key
- OG002
- arm label
- mUC Population
- regimen
- Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Overall Safety Population (OSP)
- regimen
- Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01631552-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- nct id
- NCT01631552
- harm key
- EG000
- source section id
- NCT01631552-ae
- event group key
- EG000
- event group label
- Overall Safety Population
- serious affected
- 192
- serious at risk
- 495
- other affected
- 490
- other at risk
- 495
- frequency threshold
- 5
- collection period
- - Adverse Events: First dose date up to 91.88 months plus 30 days - All-Cause Mortality: First dose date up to 91.88 months
- event definition
- Overall Safety Population: All participants who received at least 1 dose of SG. Per planned analysis, data were collected for the Overall Safety Population, pooling all participants regardless of dose level received.
- 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
- setting source links
Preserved source evidence · Not medical advice