STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.
• Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)
• Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
• Between ≥18 years of age
• Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy
• Baseline LVEF ≥ 50%
• Prior cancers allowed if no evidence of disease in last 5 years
• ECOG 0-2
• No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy
• Adequate bone marrow function:
⁃ I. ANC ≥ 1000/uL II. platelet count ≥ 100,000/uL III. hemoglobin ≥ 9.0 g/dL
⁃ • Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN
• Adequate renal function, Creatinine \< 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
• Ability to understand the nature of this study protocol and give written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures