Trial Outcomes & Findings for Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive (NCT NCT00372424)

Last Updated: 2012-12-28

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

From screening until 28 days post last dose of study drug

Results posted on

2012-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib + Docetaxel + Trastuzumab Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Study STARTED	26
Overall Study Treated	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib + Docetaxel + Trastuzumab Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1
Overall Study Death	1
Overall Study Objective Progression or Relapse	14
Overall Study Other	7
Overall Study Enrolled, Not Treated	1

Baseline Characteristics

Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Age Continuous	57.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From screening until 28 days post last dose of study drug

Population: Safety population included all participants enrolled in the study who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	24 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	11 participants

SECONDARY outcome

Timeframe: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=22 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Percentage of Participants With Objective Response (OR)	72.7 percentage of participants Interval 49.8 to 89.3

SECONDARY outcome

Timeframe: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Study population included all participants who received at least 1 dose of study medication.

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Progression-free Survival (PFS)	58.4 weeks Interval 37.0 to 66.1

SECONDARY outcome

Timeframe: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=16 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Duration of Response (DR)	51.3 weeks Interval 32.0 to 60.1

SECONDARY outcome

Timeframe: Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1

Population: Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle1/Day15 (n= 19)	40.17 nanogram/milliliter (ng/mL) Standard Deviation 32.17
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle2/Day1 (n= 17)	5.96 nanogram/milliliter (ng/mL) Standard Deviation 6.17
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle2/Day15 (n= 16)	37.29 nanogram/milliliter (ng/mL) Standard Deviation 31.07
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle4/Day1 (n= 17)	5.26 nanogram/milliliter (ng/mL) Standard Deviation 5.71
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle4/Day15 (n= 16)	43.21 nanogram/milliliter (ng/mL) Standard Deviation 27.31
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle6/Day1 (n= 16)	3.36 nanogram/milliliter (ng/mL) Standard Deviation 4.34
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib: Cycle6/Day15 (n= 13)	28.46 nanogram/milliliter (ng/mL) Standard Deviation 21.19
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle1/Day15 (n= 19)	16.15 nanogram/milliliter (ng/mL) Standard Deviation 12.09
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle2/Day1 (n= 17)	4.76 nanogram/milliliter (ng/mL) Standard Deviation 3.92
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle2/Day15 (n= 16)	14.43 nanogram/milliliter (ng/mL) Standard Deviation 11.34
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle4/Day1 (n= 17)	3.95 nanogram/milliliter (ng/mL) Standard Deviation 2.57
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle4/Day15 (n= 16)	17.62 nanogram/milliliter (ng/mL) Standard Deviation 11.17
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle6/Day1 (n= 16)	2.96 nanogram/milliliter (ng/mL) Standard Deviation 2.89
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Sunitinib Metabolite: Cycle6/Day15 (n= 13)	11.54 nanogram/milliliter (ng/mL) Standard Deviation 9.66
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle1/Day15 (n= 19)	56.31 nanogram/milliliter (ng/mL) Standard Deviation 42.70
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle2/Day1 (n= 17)	10.72 nanogram/milliliter (ng/mL) Standard Deviation 9.80
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle2/Day15 (n= 16)	51.72 nanogram/milliliter (ng/mL) Standard Deviation 41.45
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle4/Day1 (n= 17)	9.21 nanogram/milliliter (ng/mL) Standard Deviation 7.97
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle4/Day15 (n= 16)	60.83 nanogram/milliliter (ng/mL) Standard Deviation 37.43
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle6/Day1 (n= 16)	6.32 nanogram/milliliter (ng/mL) Standard Deviation 7.02
Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) Total Drug: Cycle6/Day15 (n= 13)	40.00 nanogram/milliliter (ng/mL) Standard Deviation 30.04

SECONDARY outcome

Timeframe: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Concentration values below the lower limit of quantification were taken as zero.

Outcome measures

Outcome measures
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 Participants Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Maximum Observed Plasma Concentration (Cmax) of Docetaxel Cycle1/Day1 (n= 23)	1117.05 ng/mL Standard Deviation 1159.53
Maximum Observed Plasma Concentration (Cmax) of Docetaxel Cycle2/Day1 (n= 19)	1388.63 ng/mL Standard Deviation 1260.94
Maximum Observed Plasma Concentration (Cmax) of Docetaxel Cycle4/Day1 (n= 16)	1316.88 ng/mL Standard Deviation 1096.97
Maximum Observed Plasma Concentration (Cmax) of Docetaxel Cycle6/Day1 (n= 15)	1670.40 ng/mL Standard Deviation 1614.07

SECONDARY outcome

Timeframe: Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.

Ctrough = the concentration prior to study medication administration.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: Data not analyzed since paclitaxel was not administered in the study.

Outcome measures

Outcome data not reported

Adverse Events

Sunitinib + Docetaxel + Trastuzumab

Serious events: 11 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 participants at risk Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Blood and lymphatic system disorders Febrile neutropenia	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal perforation	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Multi-organ failure	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pseudomembranous colitis	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pathological fracture	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Sunitinib + Docetaxel + Trastuzumab n=25 participants at risk Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Blood and lymphatic system disorders Anaemia	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	56.0% 14/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	20.0% 5/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Lacrimation increased	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	28.0% 7/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	60.0% 15/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	44.0% 11/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	28.0% 7/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	28.0% 7/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	60.0% 15/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	52.0% 13/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Drug hypersensitivity	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis viral	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 5/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	32.0% 8/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensory neuropathy	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	28.0% 7/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.0% 4/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	36.0% 9/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 5/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	20.0% 5/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	24.0% 6/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Phlebitis	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER