Trial Outcomes & Findings for Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer (NCT NCT00777101)
NCT ID: NCT00777101
Last Updated: 2018-08-09
Results Overview
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
From randomization date to progression or death, assessed up to 69 months
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
Neratinib
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
|
Overall Study
Treated
|
116
|
115
|
|
Overall Study
COMPLETED
|
55
|
65
|
|
Overall Study
NOT COMPLETED
|
62
|
51
|
Reasons for withdrawal
| Measure |
Neratinib
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Death
|
48
|
43
|
|
Overall Study
Withdrawal by Subject
|
11
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Discontinuation of Study by Sponsor
|
1
|
0
|
|
Overall Study
Failed to Return
|
0
|
1
|
Baseline Characteristics
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
104 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 10.11 • n=93 Participants
|
54.7 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
54.3 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
233 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From randomization date to progression or death, assessed up to 69 monthsPopulation: Intent to Treat population, includes all subjects who were randomized.
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival
|
4.53 months
Interval 3.12 to 5.65
|
6.83 months
Interval 5.85 to 8.21
|
SECONDARY outcome
Timeframe: From randomization date to death, assessed up to 69 monthsPopulation: Intent to Treat population, includes all subjects who were randomized.
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
19.74 months
Interval 18.2 to
Insufficient number of participants to calculate the upper bound of the confidence interval.
|
23.62 months
Interval 18.0 to
Insufficient number of participants to calculate the upper bound of the confidence interval.
|
SECONDARY outcome
Timeframe: From randomization date to progression or last tumor assessment, assessed up to 69 monthsPopulation: Intent to Treat population, includes all subjects who were randomized.
Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate (ORR).
|
29.1 percentage of participants
Interval 21.0 to 38.2
|
40.5 percentage of participants
Interval 31.5 to 50.0
|
SECONDARY outcome
Timeframe: From randomization date to progression or last tumor assessment, assessed up to 69 monthsPopulation: Intent to Treat population, includes all subjects who were randomized.
Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Clinical Benefit (CB) = CR + PR + SD \>= 24 weeks.
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Clinical Benefit Rate
|
44.4 percentage of participants
Interval 35.3 to 53.9
|
63.8 percentage of participants
Interval 54.4 to 72.5
|
SECONDARY outcome
Timeframe: From start date of response to first PD, assessed up to 69 months after the first subject was randomized.Population: No. of Subjects with either complete or partial response.
Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Neratinib
n=34 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=47 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response
|
12.48 months
Interval 8.31 to 14.75
|
7.98 months
Interval 5.49 to 11.76
|
SECONDARY outcome
Timeframe: From randomization date to first CNS symptom or lesionsPopulation: Intent to Treat population, includes all subjects who were randomized.
The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Frequency of CNS Metastases (Frequency)
|
9.4 percentage of participants
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization date to first CNS symptom or lesionsPopulation: Intent to Treat population, includes all subjects who were randomized.
Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).
Outcome measures
| Measure |
Neratinib
n=117 Participants
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=116 Participants
Lapatinib plus Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to CNS Metastases
|
19.68 months
Interval 19.68 to 20.99
|
NA months
Insufficient number of participants with events to calculate the median and confidence intervals.
|
Adverse Events
Neratinib
Serious events: 31 serious events
Other events: 113 other events
Deaths: 0 deaths
Lapatinib+Capecitabine
Serious events: 24 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib
n=116 participants at risk
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=115 participants at risk
Lapatinib+Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Cardiac disorders
Acute myocardial infarction
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Ascites
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
3.5%
4/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
2.6%
3/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
2.6%
3/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Asthenia
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Chills
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Disease progression
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Fatigue
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
1.7%
2/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Pain
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Pyrexia
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
2.6%
3/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Sudden death
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Bronchopneumonia
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Cellulitis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Device related infection
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Erysipelas
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Mastitis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Pneumonia
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
1.7%
2/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Sepsis
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Skin infection
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Brain oedema
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Dizziness
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
1.7%
2/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Headache
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Presyncope
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
2/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
4/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Vascular disorders
Circulatory collapse
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Vascular disorders
Deep vein thrombosis
|
0.86%
1/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Vascular disorders
Hypotension
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.87%
1/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
Other adverse events
| Measure |
Neratinib
n=116 participants at risk
Neratinib
Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity
|
Lapatinib+Capecitabine
n=115 participants at risk
Lapatinib+Capecitabine
Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
9/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
4.3%
5/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
5/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
10.4%
12/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
5/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
14.8%
17/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
11/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
12.2%
14/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
8/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
10.4%
12/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Constipation
|
6.9%
8/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
10.4%
12/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Diarrhoea
|
86.2%
100/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
71.3%
82/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Dyspepsia
|
11.2%
13/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
9.6%
11/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Nausea
|
43.1%
50/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
41.7%
48/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
9/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
24.3%
28/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Gastrointestinal disorders
Vomiting
|
32.8%
38/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
21.7%
25/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Asthenia
|
19.0%
22/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
11.3%
13/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Fatigue
|
25.9%
30/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
26.1%
30/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Influenza like illness
|
3.4%
4/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Mucosal inflammation
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
16.5%
19/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Pain
|
6.0%
7/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
7.0%
8/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
General disorders
Pyrexia
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
23.5%
27/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Cystitis
|
6.0%
7/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
4.3%
5/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Paronychia
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
20.9%
24/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
4.3%
5/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Infections and infestations
Urinary tract infection
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
11/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
13.0%
15/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
10/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
16.5%
19/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
8/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
3.5%
4/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Investigations
Weight decreased
|
12.9%
15/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
11.3%
13/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.4%
33/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
20.0%
23/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
6.1%
7/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
7/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
3.5%
4/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
13/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
4.3%
5/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
0.00%
0/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Dizziness
|
5.2%
6/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
11.3%
13/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Dysgeusia
|
3.4%
4/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
7.0%
8/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Headache
|
20.7%
24/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
10.4%
12/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
5/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Psychiatric disorders
Insomnia
|
7.8%
9/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
7.0%
8/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
17/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
9/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
6.1%
7/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
7/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
8/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
8.7%
10/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.6%
3/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
11.3%
13/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.8%
9/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
67.0%
77/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
4/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
14.8%
17/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.4%
26/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
35.7%
41/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
5.2%
6/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/116 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
10.4%
12/115 • From First Dose through 28 days after last dose, assessed up to 69 months.
See below
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60