7 days Lead-in period:
Metformin: 850mg (one tablet) twice a day
Simvastatin: 20mg (one tablet) once every night
Once the doctor has deemed that patients have tolerated Simvastatin and Metformin well, patients will receive Fulvestrant at standard doses:
Cycle 1: 500mg (in the form of two injections, 1 in each buttock) at Day 1 and Day 15. Each cycle comprises of 28 consecutive days starting from Day 1.
Cycle 2 and beyond: 500mg at Day 1 of each 28-day cycle.

Breast Cancer

7 days Lead-in period: Metformin: 850mg (one tablet) twice a day Simvastatin: 20mg (one tablet) once every night
Once the doctor has deemed that patients have tolerated Simvastatin and Metformin well, patients will receive Fulvestrant at standard doses:
Cycle 1: 500mg (in the form of two injections, 1 in each buttock) at Day 1 and Day 15. Each cycle comprises of 28 consecutive days starting from Day 1.
Cycle 2 and beyond: 500mg at Day 1 of each 28-day cycle.
Tumour biopsy at 8 weeks. Every 8 weeks for the first 6 months, every 12 weeks thereafter:
Performance status evaluation Medical history and physical examination Clinical tumor measurement Review of treatment-related side-effects Blood taking for research purpose and routine blood tests Routine scans

Metformin/Simvastatin/Fulvestrant

National University Hospital Singapore

Metformin and Simvastatin in Addition to Fulvestrant

Single Arm Phase 2 Study of Metformin and Simvastatin in Addition to Fulvestrant in Metastatic Estrogen Receptor Positive Breast Cancer

the percentage achieving CR, PR and SD in patients with measurable disease or the absence of disease progression in patients with non-measurable disease, lasting at least 24 weeks.

the time from the date of study enrollment until the first date of documented disease progression or death due to any cause, whichever occurs first.

as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

National University Hospital, Singapore

Patients with acute coronary syndrome with ST elevation and fibrinogen receiving a dose of 400 mg every 24 hours of Bezafibrate in addition to conventional anti-ischemic treatment

Patients with acute coronary syndrome with ST elevation and hyperfibrinogenemia who received only conventional anti-ischemic treatment

Acute Myocardial Infarction

Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day or just conventional therapy

Bezafibrate

Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

Early Effect Of Bezafibrate On Fibrinogen Levels, Inflammatory Response And Clinical Impact, In Patients With ST Elevation Acute Myocardial Infarction

PT-Fibrinogen HS Plus kit (Beckman Coulter, Brea, CA) to determine prothrombin time and fibrinogen and to evaluate extrinsic pathway of coagulation in citrated human plasma using an auto-analyzer ACL-800 (Cobas, Roche Diagnostics, Indianapolis, IN) where fibrinogen levels are determined through turbidimetry.

Concentration of cytokines (IL-8, IL-1β, IL-6, IL-10, TNF e IL-12) measured by ELISA system (Biosource)

angina, reinfarction, heart failure, death, and combined endpoints

Any side effect that comes with the intake of bezafibrate

rhabdomyolysis/diarrea

Metformin and Simvastatin in Addition to Fulvestrant

Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

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