Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

• Status: Suspended
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Atorvastatin

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