Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00770809
First received: October 9, 2008
Last updated: May 7, 2015
Last verified: March 2015
Results First Received: May 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HER2/Neu Positive
Male Breast Carcinoma
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions: Drug: Lapatinib Ditosylate
Biological: Trastuzumab
Drug: Paclitaxel
Other: Laboratory Biomarker Analysis

  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
Arm I (THL) Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (TH) Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm III (TL) Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)

Participant Flow:   Overall Study
    Arm I (THL)     Arm II (TH)     Arm III (TL)  
STARTED     118     120     67  
COMPLETED     101     110     44  
NOT COMPLETED     17     10     23  
Adverse Event                 9                 1                 12  
Death                 1                 0                 0  
Withdrawal by Subject                 3                 3                 7  
Progression                 2                 2                 0  
Complicating illness                 0                 0                 1  
Other Medical Reasons                 2                 4                 3  



  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
Arm I (THL) Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (TH) Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm III (TL) Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
Total Total of all reporting groups

Baseline Measures
    Arm I (THL)     Arm II (TH)     Arm III (TL)     Total  
Number of Participants  
[units: participants]
  118     120     67     305  
Age  
[units: years]
Median (Full Range)
  48.5   (24.7 to 70.8)     50.3   (30.2 to 75.8)     48.3   (25.8 to 74.3)     49.4   (24.7 to 75.8)  
Gender  
[units: participants]
       
Female     117     119     67     303  
Male     1     1     0     2  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     1     1     0     2  
Asian     4     8     5     17  
Native Hawaiian or Other Pacific Islander     0     1     0     1  
Black or African American     12     8     7     27  
White     95     97     51     243  
More than one race     2     0     0     2  
Unknown or Not Reported     4     5     4     13  
Region of Enrollment  
[units: participants]
       
United States     118     120     67     305  
Clinical Stage [1]
[units: participants]
       
Stage II     81     80     48     209  
Stage III     37     40     19     96  
Hormone Receptor Status  
[units: participants]
       
ER/PgR Positive     70     70     39     179  
ER/PgR or Negative     48     50     28     126  
[1] The American Joint Committee on Cancer (AJCC) has designated staging by tumor, node, and metastasis (TNM) classification. Stage II participants had primary tumors 0-5 cm and no regional lymph node metastases or metastases to movable ipsilateral level I, II axillary lymph node or primary tumors > 5.1 cm and no regional lymph node metastases. Stage III participants had primary tumors of any size but not any metastases in ipsilateral infraclavicular (level III axillary) lymph node(s) with or without level I, II axillary lymph node involvement



  Outcome Measures

1.  Primary:   pCR Rate   [ Time Frame: At time of surgery ]

2.  Secondary:   Pathologic Stage in the Breast and Axilla   [ Time Frame: At time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Radiographic Response Rate (at Completion of Neoadjuvant Therapy)   [ Time Frame: Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Time from randomization to death or last follow-up (up to 10 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Relapse-free Survival (RFS)   [ Time Frame: Time from surgery to any recurrence (up to 10 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Time to First Failure   [ Time Frame: Time from study entry to any recurrence ( up to 10 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3   [ Time Frame: Up to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Lisa Carey, M.D.
Organization: University of North Carolina – Lineberger Comprehensive Cancer Center
e-mail: lisa_carey@med.unc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00770809     History of Changes
Other Study ID Numbers: NCI-2009-01073, NCI-2009-01073, CDR0000616648, CALGB 40601, CALGB-40601, U10CA031946, U10CA180821
Study First Received: October 9, 2008
Results First Received: May 7, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration