Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer (SIMPHONY)
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|ClinicalTrials.gov Identifier: NCT03324425|
Recruitment Status : Not yet recruiting
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage IV||Drug: Simvastatin 40mg||Phase 2|
This study is recruiting participants with metastatic breast cancer that is HER2 positive. "Metastatic" means that cancer has spread to areas of the body outside of the breast. "HER2 positive" means that a cancer cell has too many HER2 receptors on its surface. HER2 receptors act like copy machines, and help tell cancer cells to grow and multiply.
Drugs known as HER2-targeted therapies are often used to treat HER2-positive cancers. HER2-targeted therapies work by blocking the HER2 protein from telling the cell to grow and divide. Once the protein stops working, the cancer cells can no longer make copies of themselves. Once a cancer cell becomes unable to make copies of itself, the tumor will start to shrink. However, some tumors are able to find other ways to make copies of themselves, even when the HER2 protein is blocked. When this happens, the cancer will start to grow again. Researchers believe that adding a drug called simvastatin to an anti-HER2 therapy regimen may cause the cancer to start responding again to your HER2-medications.
Simvastatin is a drug that is approved by the Food and Drug Administration (FDA) to treat high cholesterol. Laboratory research has shown that simvastatin together with dual HER2-targeted therapy slows the growth of breast cancer tumors that had been growing on dual HER2-targeting therapy alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single Arm Trial of Adding Simvastatin to Dual Anti-HER2 Therapy in Patients With HER2-Positive Metastatic Breast Cancer|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2025|
Simvastatin 40 mg in combination with anti-HER2 therapy regimen
Drug: Simvastatin 40mg
Participants will receive simvastatin 40 mg by mouth daily at bedtime
Other Name: Zocor
- Objective Response [ Time Frame: Up to approximately 24 months ]Objective response is defined as complete response or partial response, according to RECIST criteria.
- Clinical benefit [ Time Frame: Up to approximately 24 months ]Clinical benefit is defined as the number of objective responses plus the number of participants with stable disease lasting greater than 24 weeks
- Duration of Response [ Time Frame: Up to approximately 24 months ]The length of time participants have a partial response, complete response or stable disease prior to disease progression
- Time to Progression [ Time Frame: Up to approximately 24 months ]The length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body
- Number of treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria v. 4.0 (CTCAE v. 4.0). [ Time Frame: Up to approximately 24 months ]This is the number of side effects reported by participants receiving simvastatin in combination with HER2-therapy.
- HMG-CoA Reductase and HMG-CoA Synthase 1 protein levels in baseline and post-treatment tumor biopsies [ Time Frame: Up to approximately 24 months ]This measures the levels of certain enzymes in a tumor that help scientists understand how simvastatin is affecting the cancer cells.
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): NCT03324425
|Contact: Jana Knezevic, Ph.D.||firstname.lastname@example.org|
|Contact: Anne Pavlick, BSemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jana Knezevic, Ph.D. 713-798-1975 firstname.lastname@example.org|
|Principal Investigator: Mothaffar Rimawi, MD|