STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Trinitas Hospital and Comprehensive Cancer Center
RECRUITING
Elizabeth
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
RECRUITING
Hamilton
RWJBarnabas Health - - Jersey City Medical Medical
RECRUITING
Jersey City
Monmouth Medical Center Southern Campus
RECRUITING
Lakewood
Monmouth Community Medical
RECRUITING
Long Branch
RWJBarnabas Health - Monmouth Medical Center
RECRUITING
Long Branch
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital
NOT_YET_RECRUITING
New Brunswick
RWJBarnabas Health - Newark Beth Israel Medical Center
RECRUITING
Newark
RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITING
Somerset
Contact Information
Primary
Mridula George, MD
mridula@cinj.rutgers.edu
732-235-9081
Backup
Coral Omene, MD
co273@cinj.rutgers.edu
732-235-3374
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 60
Treatments
Experimental: Anti-HER2 targeted therapy + Lipitor 40mg daily
Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov

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