Trial Outcomes & Findings for A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (NCT NCT04721977)

NCT ID: NCT04721977

Last Updated: 2026-01-09

Results Overview

cORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR), per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 millimeter(mm). PR: a \>=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented progressive disease(PD) or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study(included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months)
• Results posted on: 2026-01-09

Participant Flow

A total of 66 participants were enrolled in this study across Japan, Taiwan and South Korea. Results reported are based on the primary completion date of the study.

Participant milestones

Measure	Tucatinib + Capecitabine + Trastuzumab Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.
Overall Study STARTED	66
Overall Study Japanese Participants	53
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Measure	Tucatinib + Capecitabine + Trastuzumab Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.
Overall Study Death	15
Overall Study Ongoing	51

Baseline Characteristics

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)

Baseline characteristics by cohort

Measure	Tucatinib + Capecitabine + Trastuzumab n=66 Participants Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.
Age, Continuous	54.6 Years STANDARD_DEVIATION 10.3 • n=8 Participants
Sex: Female, Male Female	66 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=8 Participants
Race/Ethnicity, Customized Asian	66 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic, Latino/a, or of Spanish Origin	66 Participants n=8 Participants

PRIMARY outcome

Timeframe: From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months)

Population: Response evaluable set for Japanese population included all Japanese participants enrolled in Japanese sites who met all of the following criteria: (1) had measurable disease at baseline, (2) received any amount of study treatment, and (3) had at least one post baseline disease assessment or discontinued due to clinical progression, toxicity, or death. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

cORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR), per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeter(mm). PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented progressive disease(PD) or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study(included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.

Outcome measures

Measure

Tucatinib + Capecitabine + Trastuzumab n=48 Participants Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.

Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants

35.4 Percentage of participants Interval 24.0 to 48.3

SECONDARY outcome

Timeframe: From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by INV. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date

PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date

PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date

PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date

PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to date of death from any cause or censoring date

OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to date of death from any cause or censoring date

OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse event was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. t intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study treatment to up to 30 days after last dose of study treatment

Outcome measures

Outcome data not reported

Adverse Events

Tucatinib + Capecitabine + Trastuzumab

Serious events: 6 serious events

Other events: 65 other events

Deaths: 15 deaths

Serious adverse events

Measure	Tucatinib + Capecitabine + Trastuzumab n=66 participants at risk Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Infections and infestations COVID-19	3.0% 2/66 • Number of events 2 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Infections and infestations Pneumonia bacterial	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Metabolism and nutrition disorders Hypercalcaemia	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Metabolism and nutrition disorders Hypophagia	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Nervous system disorders Brain oedema	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/66 • Number of events 1 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.

Other adverse events

Measure	Tucatinib + Capecitabine + Trastuzumab n=66 participants at risk Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m\^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure.
Blood and lymphatic system disorders Anaemia	19.7% 13/66 • Number of events 16 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Abdominal pain upper	9.1% 6/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Cheilitis	6.1% 4/66 • Number of events 4 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Constipation	9.1% 6/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Diarrhoea	60.6% 40/66 • Number of events 57 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Nausea	48.5% 32/66 • Number of events 41 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Stomatitis	27.3% 18/66 • Number of events 19 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Gastrointestinal disorders Vomiting	13.6% 9/66 • Number of events 14 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
General disorders Fatigue	13.6% 9/66 • Number of events 13 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
General disorders Malaise	19.7% 13/66 • Number of events 18 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
General disorders Oedema peripheral	6.1% 4/66 • Number of events 4 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
General disorders Pyrexia	12.1% 8/66 • Number of events 9 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Hepatobiliary disorders Hepatic function abnormal	9.1% 6/66 • Number of events 9 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Infections and infestations COVID-19	13.6% 9/66 • Number of events 9 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Infections and infestations Nasopharyngitis	7.6% 5/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Infections and infestations Paronychia	15.2% 10/66 • Number of events 10 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Injury, poisoning and procedural complications Accidental overdose	9.1% 6/66 • Number of events 7 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Injury, poisoning and procedural complications Infusion related reaction	7.6% 5/66 • Number of events 5 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Alanine aminotransferase increased	30.3% 20/66 • Number of events 26 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Aspartate aminotransferase increased	24.2% 16/66 • Number of events 19 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Blood bilirubin increased	27.3% 18/66 • Number of events 28 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Blood creatinine increased	13.6% 9/66 • Number of events 22 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Lymphocyte count decreased	6.1% 4/66 • Number of events 5 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Neutrophil count decreased	28.8% 19/66 • Number of events 47 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Platelet count decreased	10.6% 7/66 • Number of events 12 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations Weight decreased	9.1% 6/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Investigations White blood cell count decreased	24.2% 16/66 • Number of events 40 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Metabolism and nutrition disorders Decreased appetite	16.7% 11/66 • Number of events 14 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Nervous system disorders Dysgeusia	7.6% 5/66 • Number of events 5 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Nervous system disorders Headache	10.6% 7/66 • Number of events 8 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Renal and urinary disorders Renal impairment	6.1% 4/66 • Number of events 4 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 4/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Skin and subcutaneous tissue disorders Alopecia	7.6% 5/66 • Number of events 8 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Skin and subcutaneous tissue disorders Dry skin	10.6% 7/66 • Number of events 7 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	62.1% 41/66 • Number of events 43 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Skin and subcutaneous tissue disorders Pruritus	6.1% 4/66 • Number of events 4 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	9.1% 6/66 • Number of events 6 • From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months) Same event may appear as both non-SAE and SAE, but 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER