Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00374322
First received: September 7, 2006
Last updated: August 14, 2014
Last verified: July 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: lapatinib
Other: placebo

  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
Women with early-stage ErbB2-overexpressing breast cancer who had not been previously treated with trastuzumab were enrolled in this Phase III study. Women who subsequently had no clinical or radiologic evidence of disease were enrolled after completion of primary neoadjuvant/adjuvant chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a Screening Period, a 1-year Treatment Period, and a Follow-up (FU) Period of up to 5 years after the date of study drug withdrawal/completion, for disease status/survival. A total of 3161 eligible participants (par.) (of the 3166 enrolled) were randomized, out of which 3147 par. received at least one dose of study treatment.

Reporting Groups
  Description
Lapatinib 1500 mg Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Placebo Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.

Participant Flow:   Overall Study
    Lapatinib 1500 mg     Placebo  
STARTED     1579     1582  
Received >=1 Dose of Study Treatment     1571     1576  
COMPLETED     322     278  
NOT COMPLETED     1257     1304  
Lost to Follow-up                 92                 90  
Protocol Violation                 8                 3  
Withdrawal by Subject                 235                 167  
Sponsor Terminated Study                 866                 990  
Physician Decision                 36                 32  
Par. Consented to Survival FU Only                 3                 1  
Sponsor Decision                 2                 3  
FU by a Non-Principal Investigator (PI)                 2                 3  
Seen in FU by a Non-Primary Investigator                 1                 0  
Severe Toxicity                 1                 0  
Site Closed                 2                 2  
Participant Changed Physician                 1                 0  
Started Another Chemotherapy Regimen                 0                 1  
Noncompliance with Study Requirements                 0                 1  
Withdrew Consent During Follow-up                 0                 5  
Did Not Receive Study Medication                 8                 6  



  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
Lapatinib 1500 mg Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Placebo Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Total Total of all reporting groups

Baseline Measures
    Lapatinib 1500 mg     Placebo     Total  
Number of Participants  
[units: participants]
  1571     1576     3147  
Age  
[units: Years]
Mean ± Standard Deviation
  51.7  ± 9.89     52.3  ± 9.94     52.0  ± 9.92  
Gender  
[units: Participants]
     
Female     1571     1576     3147  
Male     0     0     0  
Race/Ethnicity, Customized [1]
[units: Participants]
     
African American/ African Heritage     53     62     115  
American Indian or Alaskan Native     65     67     132  
Asian - Central/South Asian Heritage     20     19     39  
Asian - East Asian Heritage     236     229     465  
Asian - Japanese Heritage     1     2     3  
Asian - South East Asian Heritage     81     81     162  
Native Hawaiian or Other Pacific Islander     5     11     16  
White - Arabic/North African Heritage     3     11     14  
White - White/Caucasian/European Heritage     1126     1121     2247  
[1] Participants can appear in more than one race category.



  Outcome Measures
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1.  Primary:   Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])   [ Time Frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis]) ]

2.  Secondary:   Number of Participants Who Died (Overall Survival)   [ Time Frame: From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis]) ]

3.  Secondary:   Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)   [ Time Frame: From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis]) ]

4.  Secondary:   Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)   [ Time Frame: From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis]) ]

5.  Secondary:   Time to Central Nervous System (CNS) Recurrence   [ Time Frame: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis]) ]

6.  Secondary:   Number of Participants With CNS Recurrence   [ Time Frame: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis]) ]

7.  Secondary:   Modified Disease-free Survival (MDFS)   [ Time Frame: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years) ]

8.  Secondary:   Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])   [ Time Frame: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years) ]

9.  Secondary:   Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)   [ Time Frame: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) ]

10.  Secondary:   Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)   [ Time Frame: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) ]

11.  Secondary:   Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)   [ Time Frame: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) ]

12.  Secondary:   Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters   [ Time Frame: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit ]

13.  Secondary:   Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters   [ Time Frame: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit ]

14.  Secondary:   Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades   [ Time Frame: From the first dose of study treatment up to 12 months ]

15.  Secondary:   Number of Participants Experiencing Primary or Secondary Cardiac Events   [ Time Frame: From the date of randomization up to 12 months ]

16.  Secondary:   Number of Participants With the Indicated Electrocardiogram (ECG) Findings   [ Time Frame: Screening and Month 12/Early Withdrawal Visit ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00374322     History of Changes
Other Study ID Numbers: EGF105485
Study First Received: September 7, 2006
Results First Received: July 17, 2014
Last Updated: August 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration