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Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast International Group
SOLTI Breast Cancer Research Group
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00553358
First received: November 1, 2007
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: May 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: Lapatinib
Biological: Trastuzumab
Drug: Paclitaxel

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lapatinib 1500 mg Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
Trastuzumab 2 mg/kg Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks

Participant Flow:   Overall Study
    Lapatinib 1500 mg     Trastuzumab 2 mg/kg     Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg  
STARTED     154     149     152  
COMPLETED     101     137     92  
NOT COMPLETED     53     12     60  
Adverse Event                 29                 2                 32  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 0                 1                 1  
Withdrawal by Subject                 5                 0                 1  
Recurrence of Disease                 3                 4                 1  
Participant Withdrawal from Drug                 0                 0                 3  
Missing                 1                 1                 1  
Other: Reason Not Specified                 15                 4                 20  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery   [ Time Frame: Weeks 20 to 22 ]

2.  Secondary:   Number of Participants With Overall Response at Week 6   [ Time Frame: Week 6 ]

3.  Secondary:   Number of Participants With Overall Response at the Time of Surgery   [ Time Frame: Time of surgery (Weeks 20 to 22) ]

4.  Secondary:   Number of Participants With Negative Lymph Nodes at the Time of Surgery   [ Time Frame: Time of surgery (Weeks 20 to 22) ]

5.  Secondary:   Number of Participants With Actual Indicated Surgery   [ Time Frame: At surgery (Weeks 20 to 22) ]

6.  Secondary:   Estimate of Treatment Contrast for Change From Baseline in Tumor Size at Week 6 and at Surgery   [ Time Frame: Week 6 and surgery (Weeks 20 to 22) ]

7.  Secondary:   Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab   [ Time Frame: Week 6 ]

8.  Secondary:   Overall Survival   [ Time Frame: Following surgery, every 12 months until Year 10 ]
Results not yet reported.   Anticipated Reporting Date:   01/2020   Safety Issue:   No

9.  Secondary:   Disease-free Survival (DFS)   [ Time Frame: Following surgery, every 12 months until Year 10 ]
Results not yet reported.   Anticipated Reporting Date:   08/2013   Safety Issue:   No

10.  Secondary:   Number of Participants With Metabolic Response of Complete Response (mCR), Partial Response (mPR), or Stable Disease (mSD) as Determined by Positron Emission Tomography/Computed Tomography (PET/CT)   [ Time Frame: Baseline, Week 2, and Week 6 ]
Results not yet reported.   Anticipated Reporting Date:   12/2011   Safety Issue:   No

11.  Secondary:   Number of Participants With the Indicated Biomarker Expression   [ Time Frame: Baseline, Week 2, and at surgery (Weeks 20 to 22) ]
Results not yet reported.   Anticipated Reporting Date:   01/2013   Safety Issue:   No

12.  Secondary:   Number of Circulating Tumor Cells (CTC) in the Bloodstream   [ Time Frame: Baseline, Week 2 of neo-adjuvant phase (Weeks 1-34), at surgery (Weeks 20 to 22), Week 10 of adjuvant phase, 6 months after completion of adjuvant treatment, and at recurrence ]
Results not yet reported.   Anticipated Reporting Date:   01/2013   Safety Issue:   No


  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