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Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy (HELEX)

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ClinicalTrials.gov Identifier: NCT00999804
Recruitment Status : Active, not recruiting
First Posted : October 22, 2009
Results First Posted : December 12, 2016
Last Update Posted : March 14, 2017
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
GlaxoSmithKline
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Lapatinib
Drug: Letrozole
Drug: Trastuzumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between October 2011 and July 2014 at 10 study sites: Baylor College of Medicine, UAB, University of Chicago, Johns Hopkins, Duke, Indiana University, Vanderbilt, MDACC, DFCI, and Mayo Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants screened up to 28-day period.

Reporting Groups
  Description
24-week Arm

Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.

Lapatinib: 1000 mg by mouth daily

Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)

Trastuzumab: 6 mg/kg intravenously, every 3 weeks

12-week Arm

Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.

Lapatinib: 1000 mg by mouth daily

Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)

Trastuzumab: 6 mg/kg intravenously, every 3 weeks


Participant Flow:   Overall Study
    24-week Arm   12-week Arm
STARTED   85   43 
COMPLETED   64   38 
NOT COMPLETED   21   5 
Lack of Efficacy                9                2 
Adverse Event                4                3 
Withdrawal by Subject                4                0 
Death                1                0 
Ineligible                3                0 



  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.
No text entered.

Reporting Groups
  Description
24-week Arm

Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.

Lapatinib: 1000 mg by mouth daily

Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)

Trastuzumab: 6 mg/kg intravenously, every 3 weeks

12-week Arm

Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.

Lapatinib: 1000 mg by mouth daily

Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)

Trastuzumab: 6 mg/kg intravenously, every 3 weeks

Total Total of all reporting groups

Baseline Measures
   24-week Arm   12-week Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   43   128 
Age 
[Units: Years]
Median (Full Range)
 50 
 (23 to 80) 
 57 
 (38 to 88) 
 52 
 (23 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      85 100.0%      43 100.0%      128 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      15  17.6%      9  20.9%      24  18.8% 
Not Hispanic or Latino      69  81.2%      33  76.7%      102  79.7% 
Unknown or Not Reported      1   1.2%      1   2.3%      2   1.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3   3.5%      2   4.7%      5   3.9% 
Native Hawaiian or Other Pacific Islander      1   1.2%      0   0.0%      1   0.8% 
Black or African American      11  12.9%      10  23.3%      21  16.4% 
White      68  80.0%      31  72.1%      99  77.3% 
More than one race      1   1.2%      0   0.0%      1   0.8% 
Unknown or Not Reported      1   1.2%      0   0.0%      1   0.8% 


  Outcome Measures

1.  Primary:   Pathologic Complete Response   [ Time Frame: 12 or 24 week depending the arm assignment ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 12 week or 24 weeks depending on arm assignment ]

3.  Secondary:   Total Pathologic Complete Response   [ Time Frame: 12 weeks or 24 weeks depending on arm assignment ]

4.  Secondary:   Clinical Response   [ Time Frame: 12 weeks or 24 weeks depending on arm assignment ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Mothaffar Rimawi
Organization: Baylor College of Medicine
phone: 7137981311
e-mail: rimawi@bcm.edu



Responsible Party: Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00999804     History of Changes
Other Study ID Numbers: H-25846
First Submitted: October 21, 2009
First Posted: October 22, 2009
Results First Submitted: December 29, 2015
Results First Posted: December 12, 2016
Last Update Posted: March 14, 2017