Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00912340|
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Everolimus Biological: Trastuzumab||Phase 2|
Breast cancer is the most common type of invasive cancer in women, with more than 1 million cases and almost 600,000 deaths occurring worldwide annually. Breast cancer that has spread to other parts of the body (metastasized) is usually not curable. Patients with a type of metastatic breast cancer that has hormone receptors on the surface of the cancer cells are usually treated with the drug tamoxifen, which interferes with the function of these hormone receptors. However, the average survival time for these patients remains at around 36 months.
In patients who no longer respond to tamoxifen (hormone-refractory breast cancer), the cancer drug trastuzumab (Herceptin), which acts on a protein called human epidermal growth factor receptor 2 (HER2), may have some activity. In addition, studies suggest that the drug everolimus, which acts on a pathway within cancer cells that is important for growth of the tumor, may make the cancer cells more sensitive to treatment with trastuzumab. Thus, the two drugs may act together to increase their anti-cancer potential.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
Other Name: Herceptin
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
Experimental: Trastuzumab and everolimus (ARM REMOVED)
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
Other Name: Herceptin
- Progression-free Survival (PFS) Until First Progression [ Time Frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years ]Median PFS will be calculated based on time to first progression or death.
- Progression-free Survival (PFS) in Patients Who Crossed Over [ Time Frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years ]Median PFS will be calculated based on time to first progression or death.
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): NCT00912340
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center of Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Elisavet Paplomata, MD||Emory University Winship Cancer Institute|