Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted (NCT05559164) | Clinical Trial Compass
RecruitingPhase 2
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
United States60 participantsStarted 2022-09-19
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 …
What they're measuring
1
Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Timeframe: Five years
Trial details
NCT IDNCT05559164
SponsorRutgers, The State University of New Jersey