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PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499681
First Posted: July 11, 2007
Last Update Posted: August 10, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
Results First Submitted: October 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: lapatinib ditosylate
Drug: letrozole
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
This study was open from 07/12/2007 through 12/09/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a two-part study. Part I consists of two arms: investigational drug plus Letrozole or placebo and Letrozole. Part II is Letrozole plus Lapatinib. Six patients signed consent. Two patients had toxicity or relapse, thus withdrew from the study.

Reporting Groups
  Description
Lapatinib + Letrozole, Then Lapatinib + Letrozole Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
Placebo + Letrozole, Then Lapatinib + Letrozole Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks

Participant Flow:   Overall Study
    Lapatinib + Letrozole, Then Lapatinib + Letrozole   Placebo + Letrozole, Then Lapatinib + Letrozole
STARTED   4   2 
COMPLETED   4   0 
NOT COMPLETED   0   2 
toxicity                0                1 
disease progression                0                1 



  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 + Letrozole, Then Lapatinib + Letrozole Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
Placebo + Letrozole, Then Lapatinib + Letrozole Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
Total Total of all reporting groups

Baseline Measures
   Lapatinib + Letrozole, Then Lapatinib + Letrozole   Placebo + Letrozole, Then Lapatinib + Letrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   2   6 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   0   3 
>=65 years   1   2   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (1)   74  (1)   62  (1) 
Gender 
[Units: Participants]
     
Female   4   2   6 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   4   2   6 


  Outcome Measures

1.  Primary:   Number of Participants With a Pathological Complete Response   [ Time Frame: at 14 weeks ]


  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
Due to the restrictive nature of the eligibility criteria, only a total of 6 out of the planned 36 patients were accrued in 2 years, leading to early termination of the study. Hence, both clinical and correlative data were deemed uninterpretable.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ingrid Mayer, MD, Principal Investigator
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-2033
e-mail: ingrid.mayer@vanderbilt.edu



Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00499681     History of Changes
Other Study ID Numbers: VICC BRE 0660
VU-VICC-BRE-0660
VU-VICC-061102
GSK-LAP107087
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: October 17, 2011
Results First Posted: July 10, 2012
Last Update Posted: August 10, 2012