NCT04579380 · STUDY IN CONTEXT

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).

The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.

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secondary · NOT_POSTED

DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.

Source null

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secondary · NOT_POSTED

DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least \>=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.

Source null

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secondary · NOT_POSTED

PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.

Source null

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secondary · NOT_POSTED

OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.

Source null

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secondary · NOT_POSTED

An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-uterine-neoplasm
nct id: NCT04579380
trial label: Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 9
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
source section id
NCT04579380-om-0000
source outcome index
0
endpoint
Confirmed Objective Response Rate (cORR) as Assessed by Investigator
endpoint definition
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
time origin
From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.
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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0001
source section id
NCT04579380-om-0001
source outcome index
1
endpoint
Confirmed Disease Control Rate (DCR) as Assessed by Investigator
endpoint definition
DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.
time origin
From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months)
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population 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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0002
source section id
NCT04579380-om-0002
source outcome index
2
endpoint
Duration of Response (DOR) as Assessed by Investigator
endpoint definition
DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least \>=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
time origin
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population 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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0003
source section id
NCT04579380-om-0003
source outcome index
3
endpoint
Progression-Free Survival (PFS) as Assessed by Investigator
endpoint definition
PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
time origin
From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population 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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0004
source section id
NCT04579380-om-0004
source outcome index
4
endpoint
Overall Survival (OS)
endpoint definition
OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.
time origin
From date of start of study treatment until date of death or censoring date (approximately 52.7 months)
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population 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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0005
source section id
NCT04579380-om-0005
source outcome index
5
endpoint
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
endpoint definition
An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.
time origin
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
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-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG000
arm label
Tucatinib+Trastuzumab (Cohort 1)
regimen
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG001
arm label
Tucatinib+Trastuzumab (Cohort 2)
regimen
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG002
arm label
Tucatinib+Trastuzumab (Cohort 3)
regimen
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG003
arm label
Tucatinib+Trastuzumab (Cohort 4)
regimen
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG004
arm label
Tucatinib+Trastuzumab (Cohort 5)
regimen
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG005
arm label
Tucatinib+Trastuzumab (Cohort 6)
regimen
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG006
arm label
Tucatinib+Trastuzumab (Cohort 7)
regimen
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG007
arm label
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
regimen
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
outcome key
om-0000
arm key
OG008
arm label
Tucatinib+Trastuzumab (Cohort 9)
regimen
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579380-om-0000#groups/OG008

harms

release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT04579380
harm key
EG000
source section id
NCT04579380-ae
event group key
EG000
event group label
Tucatinib+Trastuzumab (Cohort 1)
serious affected
5
serious at risk
11
other affected
10
other at risk
11
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG001
source section id
NCT04579380-ae
event group key
EG001
event group label
Tucatinib+Trastuzumab (Cohort 2)
serious affected
11
serious at risk
31
other affected
30
other at risk
31
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG002
source section id
NCT04579380-ae
event group key
EG002
event group label
Tucatinib+Trastuzumab (Cohort 3)
serious affected
13
serious at risk
30
other affected
29
other at risk
30
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG003
source section id
NCT04579380-ae
event group key
EG003
event group label
Tucatinib+Trastuzumab (Cohort 4)
serious affected
9
serious at risk
25
other affected
23
other at risk
25
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG004
source section id
NCT04579380-ae
event group key
EG004
event group label
Tucatinib+Trastuzumab (Cohort 5)
serious affected
2
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG005
source section id
NCT04579380-ae
event group key
EG005
event group label
Tucatinib+Trastuzumab (Cohort 6)
serious affected
9
serious at risk
31
other affected
29
other at risk
31
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG006
source section id
NCT04579380-ae
event group key
EG006
event group label
Tucatinib+Trastuzumab (Cohort 7)
serious affected
7
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG007
source section id
NCT04579380-ae
event group key
EG007
event group label
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
serious affected
8
serious at risk
31
other affected
31
other at risk
31
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
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-uterine-neoplasm
nct id
NCT04579380
harm key
EG008
source section id
NCT04579380-ae
event group key
EG008
event group label
Tucatinib+Trastuzumab (Cohort 9)
serious affected
14
serious at risk
33
other affected
30
other at risk
33
frequency threshold
5
collection period
From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
event definition
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice