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Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111825
First Posted: April 28, 2010
Last Update Posted: November 7, 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: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Temsirolimus
Drug: Neratinib

  Participant Flow
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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
Phase 1 Phase I, HER - Amplified (HER2-Positive) cohort
Phase 2 Triple -ve Phase 2, Triple - Negative cohort
Phase 2 HER2+ Phase 2, HER2 - Amplified (HER2-Positive) cohort
Phase 2 HER2+ Dose Esc Phase 2, HER2 - Positive cohort with dose escalation

Participant Flow:   Overall Study
    Phase 1   Phase 2 Triple -ve   Phase 2 HER2+   Phase 2 HER2+ Dose Esc
STARTED   8   6   37   48 
COMPLETED [1]   5   5   29   27 
NOT COMPLETED   3   1   8   21 
Withdrawal by Subject                0                0                1                0 
Lost to Follow-up                0                0                3                1 
Adverse Event                2                1                4                0 
Disease Progression                1                0                0                0 
Discontinuation by Sponsor                0                0                0                20 
[1] Completed means completed study or died.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Phase 1 Phase I, HER - Amplified (HER2-Positive) cohort
Phase 2 Triple -ve Phase 2, Triple - Negative cohort
Phase 2 HER2+ Phase 2, HER2 - Amplified (HER2-Positive) cohort
Phase 2 HER2+ Dose Esc Phase 2, HER2 - Positive cohort with dose escalation
Total Total of all reporting groups

Baseline Measures
   Phase 1   Phase 2 Triple -ve   Phase 2 HER2+   Phase 2 HER2+ Dose Esc   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   6   37   48   99 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  87.5%      5  83.3%      34  91.9%      39  81.3%      85  85.9% 
>=65 years      1  12.5%      1  16.7%      3   8.1%      9  18.8%      14  14.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.5  (10.4)   53.5  (13.0)   52.0  (8.3)   53.2  (11.0)   52.3  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      8 100.0%      6 100.0%      37 100.0%      47  97.9%      98  99.0% 
Male      0   0.0%      0   0.0%      0   0.0%      1   2.1%      1   1.0% 


  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR) (Phase II)   [ Time Frame: From enrollment date to first documented response, or last tumor assessment, assessed up to two years ]

2.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: From enrollment date to first documented response, or last tumor assessment, assessed up to two years ]

3.  Secondary:   Duration of Response (DOR)   [ Time Frame: From first response to first PD or death, assessed up to two years. ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From date of enrollment until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to two years. ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From enrollment to date of death from any cause, or end of long term follow-up, assessed up to three years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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



Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01111825     History of Changes
Other Study ID Numbers: 10-005
First Submitted: April 22, 2010
First Posted: April 28, 2010
Results First Submitted: August 10, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017