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Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878709
First Posted: April 9, 2009
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: neratinib
Other: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Participant Flow:   Overall Study
    Neratinib   Placebo
STARTED   1420   1420 
COMPLETED   1095   1183 
NOT COMPLETED   325   237 
Withdrawal by Subject                197                120 
Lost to Follow-up                35                33 
Other Reasons                93                84 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Total Total of all reporting groups

Baseline Measures
   Neratinib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1420   1420   2840 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (10.08)   52.3  (10.28)   52.3  (10.18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1420 100.0%      1420 100.0%      2840 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   188   197   385 
Black or African American   27   47   74 
White   1165   1135   2300 
Other   40   41   81 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Primary
Measure Title Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm
Measure Description Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm 
[Units: Percentage of participants with events]
 4.7   7.5 


Statistical Analysis 1 for Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Log Rank
P Value [4] 0.008
Hazard Ratio (HR) [5] 0.66
95% Confidence Interval 0.49 to 0.90
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).



2.  Primary:   Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Primary
Measure Title Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Measure Description No text entered.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 94.2 
 (92.6 to 95.4) 
 91.9 
 (90.2 to 93.2) 

No statistical analysis provided for Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms



3.  Secondary:   Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm
Measure Description Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm 
[Units: Percentage of participants with events]
 4.7   8.0 


Statistical Analysis 1 for Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm
Groups [1] All groups
Statistical Test Type [2] Superiority
Hazard Ratio (HR) [3] 0.61
95% Confidence Interval 0.45 to 0.83
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).



4.  Secondary:   Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Measure Description No text entered.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 94.2 
 (92.6 to 95.4) 
 91.3 
 (89.6 to 92.7) 

No statistical analysis provided for Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms



5.  Secondary:   Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm
Measure Description Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm 
[Units: Percentage of participants with events]
 3.8   5.4 


Statistical Analysis 1 for Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm
Groups [1] All groups
Statistical Test Type [2] Superiority
Hazard Ratio (HR) [3] 0.74
95% Confidence Interval 0.52 to 1.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).



6.  Secondary:   Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Measure Description No text entered.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 95.3 
 (93.9 to 96.4) 
 94.0 
 (92.6 to 95.2) 

No statistical analysis provided for Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms



7.  Secondary:   Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm
Measure Description Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm 
[Units: Percentage of participants with events]
 3.7   5.3 


Statistical Analysis 1 for Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm
Groups [1] All groups
Statistical Test Type [2] Superiority
Hazard Ratio (HR) [3] 0.73
95% Confidence Interval 0.51 to 1.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).



8.  Secondary:   Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Measure Description No text entered.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 95.5 
 (94.1 to 96.6) 
 94.2 
 (92.8 to 95.3) 

No statistical analysis provided for Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms



9.  Secondary:   Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm
Measure Description CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm 
[Units: Percentage of participants with events]
 0.8   1.1 

No statistical analysis provided for Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm



10.  Secondary:   Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2   [ Time Frame: From randomization until time of event up to 2 years ]

Measure Type Secondary
Measure Title Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2
Measure Description Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray’s method (Gray,1988).
Time Frame From randomization until time of event up to 2 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Measured Values
   Neratinib   Placebo 
Participants Analyzed 
[Units: Participants]
 1420   1420 
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 0.92 
 (0.49 to 1.59) 
 1.16 
 (0.68 to 1.87) 

No statistical analysis provided for Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2



11.  Secondary:   Overall Survival (OS)   [ Time Frame: From time of randomization to death ]
Results not yet reported.   Anticipated Reporting Date:   07/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: clinicaltrials@pumabiotechnology.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00878709     History of Changes
Other Study ID Numbers: 3144A2-3004
B1891004
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: August 10, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017