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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00499681
First received: July 10, 2007
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
Results First Received: October 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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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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  
Number of Participants  
[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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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.  


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


No publications provided


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
Study First Received: July 10, 2007
Results First Received: October 17, 2011
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration