Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT01205685|
Recruitment Status : Terminated (PI closed study early, all patients experienced severe toxicities and progressed)
First Posted : September 20, 2010
Results First Posted : September 11, 2012
Last Update Posted : September 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hormone-sensitive Metastatic Breast Cancer||Drug: OSI-906 Drug: Erlotinib Drug: Letrozole Drug: Goserelin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) and Erlotinib (Tarceva®, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Experimental: OSI-906 + Erlotinib + Letrozole + Goserelin
In a pill form by mouth, twice a day (12 hours apart)
During the safety run portion of the study"
During the safety run phase of the study:
In a pill form, by mouth, once per day at 2.5 mg/d.
For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.
- Anti-tumor Activity of OSI-906 [ Time Frame: From study entry to 6 months ]Time to progression measured in months from study entry to date of disease progression
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity [ Time Frame: Every 4 weeks up to 24 weeks ]According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.
- Number of Participants With Tumor Response Per RECIST [ Time Frame: Every 12 weeks to tumor progression ]Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
- Correlative Studies [ Time Frame: < or = to 2 weeks before initiation of Phase II study treatment period ]Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205685
|United States, Tennessee|
|Vanderbilt-Ingram Oncology Cool Springs|
|Franklin, Tennessee, United States, 37067|
|Vanderbilt One Hundre Oaks|
|Nashville, Tennessee, United States, 37204|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Ingrid Mayer, M.D.||Vanderbilt-Ingram Cancer Center|