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Trial record 45 of 55 for:    hki-272 OR neratinib

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer (NEFERTT)

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ClinicalTrials.gov Identifier: NCT00915018
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : November 6, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Neratinib
Drug: Trastuzumab
Drug: Paclitaxel
Enrollment 479
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
Hide Arm/Group Description

Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Period Title: Overall Study
Started 242 237
Received Treatment 240 234
Completed 27 30
Not Completed 215 207
Reason Not Completed
Death             75             70
Lost to Follow-up             10             5
Withdrawal by Subject             38             27
By Sponsor due to Protocol Amendment             92             105
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel Total
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Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Total of all reporting groups
Overall Number of Baseline Participants 242 237 479
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants 237 participants 479 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
199
  82.2%
193
  81.4%
392
  81.8%
>=65 years
43
  17.8%
44
  18.6%
87
  18.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 242 participants 237 participants 479 participants
54.0  (11.6) 54.3  (11.0) 54.1  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants 237 participants 479 participants
Female
242
 100.0%
237
 100.0%
479
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival
Hide Description Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
Time Frame From randomization to disease progression or death, assessed up to 5.3 years
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Hide Analysis Population Description
all randomized patients
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
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Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Overall Number of Participants Analyzed 242 237
Median (95% Confidence Interval)
Unit of Measure: months
12.9
(11.1 to 14.9)
12.9
(11.1 to 14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib + Paclitaxel, Trastuzumab + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8934
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.015
Confidence Interval (2-Sided) 95%
0.813 to 1.269
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate
Hide Description Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial 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; and Non-Progressive Disease for non-target lesions, and no new lesions.
Time Frame From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
Hide Arm/Group Description:

Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Overall Number of Participants Analyzed 242 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.8
(68.8 to 80.1)
77.6
(71.8 to 82.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib + Paclitaxel, Trastuzumab + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5219
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.028
Confidence Interval (2-Sided) 95%
-0.048 to 0.105
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response
Hide Description Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, 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; and Non-PD for non-target lesions, and no new lesions.
Time Frame From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Hide Outcome Measure Data
Hide Analysis Population Description
patients who responded
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
Hide Arm/Group Description:

Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Overall Number of Participants Analyzed 181 184
Median (95% Confidence Interval)
Unit of Measure: months
13.1
(11.1 to 15.4)
12.9
(11.0 to 15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib + Paclitaxel, Trastuzumab + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8431
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.974
Confidence Interval (2-Sided) 95%
0.752 to 1.262
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clinical Benefit Rate
Hide Description Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks 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; and Non-PD for non-target lesions, and no new 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.
Time Frame From randomization to disease progression or death, assessed up to 5.3 years
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
Hide Arm/Group Description:

Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Overall Number of Participants Analyzed 242 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.4
(83.7 to 92.2)
85.2
(80.1 to 89.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib + Paclitaxel, Trastuzumab + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2360
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.032
Confidence Interval (2-Sided) 95%
-0.093 to 0.029
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Symptomatic or Progressive Central Nervous System (CNS) Lesions
Hide Description

Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.

If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.

Time Frame From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title Neratinib + Paclitaxel Trastuzumab + Paclitaxel
Hide Arm/Group Description:

Neratinib + Paclitaxel

Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Trastuzumab + Paclitaxel

Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Overall Number of Participants Analyzed 242 237
Measure Type: Count of Participants
Unit of Measure: Participants
20
   8.3%
41
  17.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib + Paclitaxel, Trastuzumab + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.449
Confidence Interval (2-Sided) 95%
0.259 to 0.780
Estimation Comments [Not Specified]
Time Frame From First Dose through 28 days after last dose, assessed up to 5.3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neratinib+Paclitaxel Trastuzumab+Paclitaxel
Hide Arm/Group Description Neratinib + Paclitaxel Trastuzumab + Paclitaxel
All-Cause Mortality
Neratinib+Paclitaxel Trastuzumab+Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neratinib+Paclitaxel Trastuzumab+Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   67/240 (27.92%)   56/234 (23.93%) 
Blood and lymphatic system disorders     
Anaemia  1  0/240 (0.00%)  1/234 (0.43%) 
Febrile neutropenia  1  1/240 (0.42%)  0/234 (0.00%) 
Leukopenia  1  2/240 (0.83%)  0/234 (0.00%) 
Neutropenia  1  1/240 (0.42%)  0/234 (0.00%) 
Thrombocytopenia  1  0/240 (0.00%)  1/234 (0.43%) 
Cardiac disorders     
Atrial fibrillation  1  0/240 (0.00%)  1/234 (0.43%) 
Cardiac failure congestive  1  2/240 (0.83%)  0/234 (0.00%) 
Cardiac tamponade  1  1/240 (0.42%)  0/234 (0.00%) 
Cardio-respiratory arrest  1  1/240 (0.42%)  0/234 (0.00%) 
Left ventricular dysfunction  1  0/240 (0.00%)  1/234 (0.43%) 
Myocardial infarction  1  1/240 (0.42%)  0/234 (0.00%) 
Pericardial effusion  1  1/240 (0.42%)  0/234 (0.00%) 
Eye disorders     
Retinal degeneration  1  1/240 (0.42%)  0/234 (0.00%) 
Uveitis  1  1/240 (0.42%)  0/234 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/240 (0.83%)  1/234 (0.43%) 
Abdominal pain upper  1  1/240 (0.42%)  0/234 (0.00%) 
Ascites  1  2/240 (0.83%)  0/234 (0.00%) 
Dental caries  1  0/240 (0.00%)  1/234 (0.43%) 
Diarrhoea  1  12/240 (5.00%)  3/234 (1.28%) 
Gastrointestinal haemorrhage  1  2/240 (0.83%)  0/234 (0.00%) 
Ileus  1  0/240 (0.00%)  1/234 (0.43%) 
Intestinal obstruction  1  1/240 (0.42%)  0/234 (0.00%) 
Nausea  1  2/240 (0.83%)  1/234 (0.43%) 
Rectal haemorrhage  1  1/240 (0.42%)  0/234 (0.00%) 
Small intestinal obstruction  1  1/240 (0.42%)  0/234 (0.00%) 
Volvulus  1  1/240 (0.42%)  0/234 (0.00%) 
Vomiting  1  7/240 (2.92%)  1/234 (0.43%) 
General disorders     
Adhesion  1  1/240 (0.42%)  0/234 (0.00%) 
Disease progression  1  3/240 (1.25%)  0/234 (0.00%) 
Fatigue  1  1/240 (0.42%)  1/234 (0.43%) 
Generalised oedema  1  1/240 (0.42%)  0/234 (0.00%) 
Multi-organ failure  1  0/240 (0.00%)  1/234 (0.43%) 
Oedema peripheral  1  1/240 (0.42%)  1/234 (0.43%) 
Pyrexia  1  3/240 (1.25%)  5/234 (2.14%) 
Sudden death  1  0/240 (0.00%)  1/234 (0.43%) 
Swelling  1  0/240 (0.00%)  1/234 (0.43%) 
Hepatobiliary disorders     
Biliary colic  1  1/240 (0.42%)  0/234 (0.00%) 
Cholelithiasis  1  0/240 (0.00%)  1/234 (0.43%) 
Hepatic failure  1  2/240 (0.83%)  1/234 (0.43%) 
Hepatitis  1  0/240 (0.00%)  1/234 (0.43%) 
Hyperbilirubinaemia  1  0/240 (0.00%)  1/234 (0.43%) 
Immune system disorders     
Contrast media allergy  1  0/240 (0.00%)  1/234 (0.43%) 
Drug hypersensitivity  1  1/240 (0.42%)  1/234 (0.43%) 
Food allergy  1  1/240 (0.42%)  0/234 (0.00%) 
Type IV hypersensitivity reaction  1  1/240 (0.42%)  0/234 (0.00%) 
Infections and infestations     
Appendicitis  1  0/240 (0.00%)  1/234 (0.43%) 
Candida infection  1  1/240 (0.42%)  0/234 (0.00%) 
Catheter site cellulitis  1  0/240 (0.00%)  1/234 (0.43%) 
Cellulitis  1  0/240 (0.00%)  6/234 (2.56%) 
Dengue fever  1  0/240 (0.00%)  1/234 (0.43%) 
Device related infection  1  2/240 (0.83%)  2/234 (0.85%) 
Empyema  1  1/240 (0.42%)  0/234 (0.00%) 
Furuncle  1  1/240 (0.42%)  0/234 (0.00%) 
Gastroenteritis  1  3/240 (1.25%)  0/234 (0.00%) 
Herpes zoster  1  0/240 (0.00%)  1/234 (0.43%) 
Infection  1  1/240 (0.42%)  0/234 (0.00%) 
Lower respiratory tract infection  1  1/240 (0.42%)  1/234 (0.43%) 
Pharyngitis  1  0/240 (0.00%)  1/234 (0.43%) 
Pleural infection  1  0/240 (0.00%)  1/234 (0.43%) 
Pneumonia  1  1/240 (0.42%)  0/234 (0.00%) 
Pulmonary tuberculosis  1  0/240 (0.00%)  1/234 (0.43%) 
Pyelonephritis acute  1  0/240 (0.00%)  1/234 (0.43%) 
Rash pustular  1  1/240 (0.42%)  0/234 (0.00%) 
Respiratory tract infection  1  0/240 (0.00%)  1/234 (0.43%) 
Septic shock  1  1/240 (0.42%)  0/234 (0.00%) 
Sinusitis  1  0/240 (0.00%)  1/234 (0.43%) 
Staphylococcal infection  1  1/240 (0.42%)  0/234 (0.00%) 
Tooth abscess  1  0/240 (0.00%)  1/234 (0.43%) 
Upper respiratory tract infection  1  2/240 (0.83%)  1/234 (0.43%) 
Urinary tract infection  1  0/240 (0.00%)  1/234 (0.43%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  2/240 (0.83%)  3/234 (1.28%) 
Ankle fracture  1  1/240 (0.42%)  0/234 (0.00%) 
Drug administration error  1  0/240 (0.00%)  1/234 (0.43%) 
Femur fracture  1  1/240 (0.42%)  0/234 (0.00%) 
Intentional overdose  1  1/240 (0.42%)  0/234 (0.00%) 
Ligament sprain  1  0/240 (0.00%)  1/234 (0.43%) 
Lower limb fracture  1  1/240 (0.42%)  0/234 (0.00%) 
Overdose  1  2/240 (0.83%)  0/234 (0.00%) 
Pneumothorax traumatic  1  0/240 (0.00%)  1/234 (0.43%) 
Procedural hypotension  1  1/240 (0.42%)  0/234 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/240 (0.42%)  0/234 (0.00%) 
Alanine aminotransferase increased  1  1/240 (0.42%)  1/234 (0.43%) 
Aspartate aminotransferase increased  1  1/240 (0.42%)  1/234 (0.43%) 
General physical condition abnormal  1  1/240 (0.42%)  0/234 (0.00%) 
Weight decreased  1  1/240 (0.42%)  0/234 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/240 (0.42%)  2/234 (0.85%) 
Dehydration  1  7/240 (2.92%)  1/234 (0.43%) 
Hyperglycaemia  1  0/240 (0.00%)  1/234 (0.43%) 
Hypokalaemia  1  3/240 (1.25%)  0/234 (0.00%) 
Hyponatraemia  1  2/240 (0.83%)  0/234 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/240 (0.00%)  1/234 (0.43%) 
Musculoskeletal chest pain  1  1/240 (0.42%)  1/234 (0.43%) 
Pain in extremity  1  0/240 (0.00%)  1/234 (0.43%) 
Rheumatoid arthritis  1  1/240 (0.42%)  0/234 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign ovarian tumour  1  1/240 (0.42%)  0/234 (0.00%) 
Cancer pain  1  0/240 (0.00%)  1/234 (0.43%) 
Gastric cancer  1  1/240 (0.42%)  0/234 (0.00%) 
Metastases to central nervous system  1  2/240 (0.83%)  5/234 (2.14%) 
Metastases to meninges  1  0/240 (0.00%)  1/234 (0.43%) 
Ovarian epithelial cancer  1  0/240 (0.00%)  1/234 (0.43%) 
Ureteric cancer  1  0/240 (0.00%)  1/234 (0.43%) 
Nervous system disorders     
Brain oedema  1  1/240 (0.42%)  0/234 (0.00%) 
Cerebellar ischaemia  1  0/240 (0.00%)  1/234 (0.43%) 
Coma  1  1/240 (0.42%)  0/234 (0.00%) 
Headache  1  1/240 (0.42%)  0/234 (0.00%) 
Transient ischaemic attack  1  1/240 (0.42%)  0/234 (0.00%) 
Psychiatric disorders     
Confusional state  1  4/240 (1.67%)  0/234 (0.00%) 
Depression  1  0/240 (0.00%)  1/234 (0.43%) 
Schizophrenia  1  0/240 (0.00%)  1/234 (0.43%) 
Renal and urinary disorders     
Prerenal failure  1  1/240 (0.42%)  0/234 (0.00%) 
Renal failure acute  1  1/240 (0.42%)  0/234 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia  1  1/240 (0.42%)  0/234 (0.00%) 
Uterine polyp  1  0/240 (0.00%)  1/234 (0.43%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/240 (0.42%)  2/234 (0.85%) 
Pleural effusion  1  1/240 (0.42%)  2/234 (0.85%) 
Pneumonia aspiration  1  0/240 (0.00%)  1/234 (0.43%) 
Pneumonitis  1  0/240 (0.00%)  2/234 (0.85%) 
Pneumothorax  1  1/240 (0.42%)  0/234 (0.00%) 
Pulmonary embolism  1  2/240 (0.83%)  0/234 (0.00%) 
Respiratory failure  1  0/240 (0.00%)  1/234 (0.43%) 
Skin and subcutaneous tissue disorders     
Erythema  1  0/240 (0.00%)  1/234 (0.43%) 
Vascular disorders     
Deep vein thrombosis  1  0/240 (0.00%)  1/234 (0.43%) 
Hypertension  1  0/240 (0.00%)  1/234 (0.43%) 
Hypotension  1  1/240 (0.42%)  0/234 (0.00%) 
Shock  1  1/240 (0.42%)  0/234 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neratinib+Paclitaxel Trastuzumab+Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   239/240 (99.58%)   230/234 (98.29%) 
Blood and lymphatic system disorders     
Anaemia  1  75/240 (31.25%)  65/234 (27.78%) 
Leukopenia  1  72/240 (30.00%)  74/234 (31.62%) 
Lymphopenia  1  32/240 (13.33%)  30/234 (12.82%) 
Neutropenia  1  77/240 (32.08%)  79/234 (33.76%) 
Gastrointestinal disorders     
Abdominal distension  1  16/240 (6.67%)  4/234 (1.71%) 
Abdominal pain  1  51/240 (21.25%)  26/234 (11.11%) 
Abdominal pain upper  1  30/240 (12.50%)  18/234 (7.69%) 
Constipation  1  35/240 (14.58%)  44/234 (18.80%) 
Diarrhoea  1  222/240 (92.50%)  78/234 (33.33%) 
Dyspepsia  1  31/240 (12.92%)  20/234 (8.55%) 
Haemorrhoids  1  4/240 (1.67%)  12/234 (5.13%) 
Nausea  1  107/240 (44.58%)  70/234 (29.91%) 
Stomatitis  1  59/240 (24.58%)  46/234 (19.66%) 
Vomiting  1  87/240 (36.25%)  37/234 (15.81%) 
General disorders     
Asthenia  1  53/240 (22.08%)  36/234 (15.38%) 
Fatigue  1  77/240 (32.08%)  64/234 (27.35%) 
Influenza like illness  1  10/240 (4.17%)  14/234 (5.98%) 
Oedema  1  11/240 (4.58%)  15/234 (6.41%) 
Oedema peripheral  1  34/240 (14.17%)  40/234 (17.09%) 
Pain  1  13/240 (5.42%)  13/234 (5.56%) 
Pyrexia  1  41/240 (17.08%)  44/234 (18.80%) 
Infections and infestations     
Cystitis  1  13/240 (5.42%)  12/234 (5.13%) 
Influenza  1  11/240 (4.58%)  13/234 (5.56%) 
Nasopharyngitis  1  29/240 (12.08%)  33/234 (14.10%) 
Paronychia  1  16/240 (6.67%)  9/234 (3.85%) 
Rhinitis  1  2/240 (0.83%)  12/234 (5.13%) 
Upper respiratory tract infection  1  26/240 (10.83%)  32/234 (13.68%) 
Urinary tract infection  1  17/240 (7.08%)  15/234 (6.41%) 
Investigations     
Alanine aminotransferase increased  1  31/240 (12.92%)  26/234 (11.11%) 
Aspartate aminotransferase increased  1  26/240 (10.83%)  22/234 (9.40%) 
Blood alkaline phosphatase increased  1  15/240 (6.25%)  11/234 (4.70%) 
Weight decreased  1  38/240 (15.83%)  12/234 (5.13%) 
Weight increased  1  8/240 (3.33%)  14/234 (5.98%) 
Metabolism and nutrition disorders     
Decreased appetite  1  76/240 (31.67%)  41/234 (17.52%) 
Dehydration  1  18/240 (7.50%)  3/234 (1.28%) 
Hypercreatininaemia  1  13/240 (5.42%)  2/234 (0.85%) 
Hyperglycaemia  1  9/240 (3.75%)  16/234 (6.84%) 
Hypocalcaemia  1  19/240 (7.92%)  4/234 (1.71%) 
Hypokalaemia  1  23/240 (9.58%)  9/234 (3.85%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  34/240 (14.17%)  44/234 (18.80%) 
Back pain  1  37/240 (15.42%)  27/234 (11.54%) 
Bone pain  1  11/240 (4.58%)  12/234 (5.13%) 
Muscle spasms  1  17/240 (7.08%)  12/234 (5.13%) 
Musculoskeletal chest pain  1  13/240 (5.42%)  5/234 (2.14%) 
Musculoskeletal pain  1  13/240 (5.42%)  18/234 (7.69%) 
Myalgia  1  31/240 (12.92%)  32/234 (13.68%) 
Pain in extremity  1  30/240 (12.50%)  25/234 (10.68%) 
Nervous system disorders     
Dizziness  1  52/240 (21.67%)  30/234 (12.82%) 
Dysgeusia  1  35/240 (14.58%)  16/234 (6.84%) 
Headache  1  49/240 (20.42%)  45/234 (19.23%) 
Hypoaesthesia  1  18/240 (7.50%)  25/234 (10.68%) 
Neuropathy peripheral  1  61/240 (25.42%)  60/234 (25.64%) 
Paraesthesia  1  21/240 (8.75%)  12/234 (5.13%) 
Peripheral sensory neuropathy  1  47/240 (19.58%)  53/234 (22.65%) 
Psychiatric disorders     
Insomnia  1  32/240 (13.33%)  28/234 (11.97%) 
Reproductive system and breast disorders     
Breast pain  1  5/240 (2.08%)  12/234 (5.13%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  24/240 (10.00%)  47/234 (20.09%) 
Dyspnoea  1  28/240 (11.67%)  22/234 (9.40%) 
Epistaxis  1  36/240 (15.00%)  20/234 (8.55%) 
Oropharyngeal pain  1  18/240 (7.50%)  20/234 (8.55%) 
Rhinorrhoea  1  6/240 (2.50%)  17/234 (7.26%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  126/240 (52.50%)  133/234 (56.84%) 
Dry skin  1  14/240 (5.83%)  12/234 (5.13%) 
Erythema  1  9/240 (3.75%)  16/234 (6.84%) 
Nail disorder  1  33/240 (13.75%)  31/234 (13.25%) 
Palmar-plantar erythrodysaesthesia syndrome  1  14/240 (5.83%)  7/234 (2.99%) 
Pruritus  1  19/240 (7.92%)  22/234 (9.40%) 
Rash  1  72/240 (30.00%)  51/234 (21.79%) 
Vascular disorders     
Hot flush  1  13/240 (5.42%)  8/234 (3.42%) 
Hypertension  1  13/240 (5.42%)  19/234 (8.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Director, Clinical Operations
Organization: Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00915018     History of Changes
Other Study ID Numbers: 3144A2-3005 / B1891005
First Submitted: June 4, 2009
First Posted: June 5, 2009
Results First Submitted: August 10, 2017
Results First Posted: November 6, 2017
Last Update Posted: August 22, 2018