Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Sep 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding statins—medications typically used to lower cholesterol—can help reduce heart problems in women with early-stage HER2 positive breast cancer who are receiving targeted therapy. The goal is to see if statins can help prevent treatment delays or the need to stop therapy early due to heart-related side effects.

To participate, women must be between 18 and 74 years old, have a confirmed diagnosis of Stage I-III breast cancer, and be scheduled for specific HER2 targeted treatments. They should have a good baseline heart function and no history of significant cardiovascular issues. Participants can expect regular visits for treatment and monitoring throughout the study. It's important to know that women who are pregnant, breastfeeding, or currently taking statins are not eligible. This trial is actively recruiting participants, and those interested should discuss with their healthcare provider to see if they qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Participants with stage IV breast cancer
• • Participants currently taking statins
• • Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
• • No active liver disease
• • Current use of CYP 3A4 inhibitors
• • Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
• • Life expectancy \< 12 weeks
• • Pregnancy (positive pregnancy test) or lactation
• • Pre-existing sensory neuropathy \> grade one
• * Has significant cardiovascular disease, such as:
• • LVEF \< 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization
• • Major surgery without complete recovery in the past four weeks prior to screening
• • Concurrent active infection
• • Participant with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C
• • Participant who has a history of allergy or hypersensitivity to any of the study drugs
• • Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis
• • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study