RecruitingCardiac ToxicityEarly-stage Breast Cancer
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Rutgers, The State University of New Jersey
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
New Jersey
Elizabeth · Hamilton · Jersey City · Lakewood …
Source: ClinicalTrials.gov · NCT05559164 · last updated 2025-11-14