NCT05132582 · ADVERSE EVENTS

Adverse events

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer · Source last updated 2026-09-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
Other-event reporting threshold: 2%

Same event may appear as both SAE and other-AE (non-SAE); however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated for adverse event information. For all-cause mortality, ITT population was evaluated.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tucatinib + Trastuzumab + Pertuzumab Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.	55 / 326	323 / 326	18 / 326
Placebo + Trastuzumab + Pertuzumab Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.	26 / 324	313 / 324	33 / 328

Group identifiers: EG000: Tucatinib + Trastuzumab + Pertuzumab · EG001: Placebo + Trastuzumab + Pertuzumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
326
num Events
2
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Mitral valve incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Vestibular disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Visual acuity reduced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
326
num Events
3
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Chest pain

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
54
num At Risk
326
num Events
93
group Id
EG001
num Affected
30
num At Risk
324
num Events
40
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
4
num At Risk
326
num Events
4
group Id
EG001
num Affected
8
num At Risk
324
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
15
num At Risk
326
num Events
33
group Id
EG001
num Affected
8
num At Risk
324
num Events
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
10
num At Risk
326
num Events
10
group Id
EG001
num Affected
7
num At Risk
324
num Events
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
8
num At Risk
326
num Events
8
group Id
EG001
num Affected
9
num At Risk
324
num Events
10
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
10
num At Risk
326
num Events
10
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
7
num At Risk
326
num Events
8
group Id
EG001
num Affected
11
num At Risk
324
num Events
11
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
8
num At Risk
326
num Events
10
group Id
EG001
num Affected
4
num At Risk
324
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
9
num At Risk
326
num Events
10
group Id
EG001
num Affected
11
num At Risk
324
num Events
12
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
26
num At Risk
326
num Events
35
group Id
EG001
num Affected
16
num At Risk
324
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
26
num At Risk
326
num Events
41
group Id
EG001
num Affected
15
num At Risk
324
num Events
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
35
num At Risk
326
num Events
41
group Id
EG001
num Affected
34
num At Risk
324
num Events
43
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
18
deaths Num At Risk
326
description
Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
id
EG000
other Num Affected
323
other Num At Risk
326
serious Num Affected
55
serious Num At Risk
326
title
Tucatinib + Trastuzumab + Pertuzumab
deaths Num Affected
33
deaths Num At Risk
328
description
Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
id
EG001
other Num Affected
313
other Num At Risk
324
serious Num Affected
26
serious Num At Risk
324
title
Placebo + Trastuzumab + Pertuzumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
54
num At Risk
326
num Events
93
group Id
EG001
num Affected
30
num At Risk
324
num Events
40
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
4
num At Risk
326
num Events
4
group Id
EG001
num Affected
8
num At Risk
324
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
15
num At Risk
326
num Events
33
group Id
EG001
num Affected
8
num At Risk
324
num Events
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
10
num At Risk
326
num Events
10
group Id
EG001
num Affected
7
num At Risk
324
num Events
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
8
num At Risk
326
num Events
8
group Id
EG001
num Affected
9
num At Risk
324
num Events
10
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
10
num At Risk
326
num Events
10
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
7
num At Risk
326
num Events
8
group Id
EG001
num Affected
11
num At Risk
324
num Events
11
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
8
num At Risk
326
num Events
10
group Id
EG001
num Affected
4
num At Risk
324
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
9
num At Risk
326
num Events
10
group Id
EG001
num Affected
11
num At Risk
324
num Events
12
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
26
num At Risk
326
num Events
35
group Id
EG001
num Affected
16
num At Risk
324
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
26
num At Risk
326
num Events
41
group Id
EG001
num Affected
15
num At Risk
324
num Events
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
35
num At Risk
326
num Events
41
group Id
EG001
num Affected
34
num At Risk
324
num Events
43
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
326
num Events
2
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Mitral valve incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Vestibular disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
326
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Visual acuity reduced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
326
num Events
3
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
326
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Chest pain

time Frame

From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)

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