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Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

This study has been terminated.
(PI closed study early, all patients experienced severe toxicities and progressed)
Sponsor:
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01205685
First received: September 17, 2010
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hormone-sensitive Metastatic Breast Cancer
Interventions: Drug: OSI-906
Drug: Erlotinib
Drug: Letrozole
Drug: Goserelin

  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 conducted from May 2010 and closed early one year later, May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 patients consented, one of which was determined to be ineligible.

Reporting Groups
  Description
OSI-906 + Erlotinib + Letrozole + Goserelin
  • OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
  • Erlotinib in a pill form, by mouth, once a day
  • Letrozole in a pill form, by mouth, once a day
  • Goserelin, by injection once per month for women who are pre-menopausal

Participant Flow:   Overall Study
    OSI-906 + Erlotinib + Letrozole + Goserelin  
STARTED     11  
COMPLETED     0  
NOT COMPLETED     11  
Disease Progression                 10  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
OSI-906 + Erlotinib + Letrozole + Goserelin
  • OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
  • Erlotinib in a pill form, by mouth, once a day
  • Letrozole in a pill form, by mouth, once a day
  • Goserelin, by injection once per month for women who are pre-menopausal

Baseline Measures
    OSI-906 + Erlotinib + Letrozole + Goserelin  
Number of Participants  
[units: participants]
 		  11  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation 		  59  ± 1  
Gender  
[units: participants]
 		 
Female     11  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     11  



  Outcome Measures
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1.  Primary:   Anti-tumor Activity of OSI-906   [ Time Frame: From study entry to 6 months ]
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2.  Secondary:   Safety Profile Based on Number of Patients With Each Worst-grade Toxicity   [ Time Frame: Every 4 weeks up to 24 weeks ]
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3.  Secondary:   Number of Participants With Tumor Response Per RECIST   [ Time Frame: Every 12 weeks to tumor progression ]
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4.  Secondary:   Correlative Studies   [ Time Frame: < or = to 2 weeks before initiation of Phase II study treatment period ]
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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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Ingrid Mayer
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: NCT01205685     History of Changes
Other Study ID Numbers: VICC BRE 09112
Study First Received: September 17, 2010
Results First Received: June 7, 2012
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration