Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Part of paid clinical trials in Elizabeth, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05559164
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiac Toxicity
  • Early-stage Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lipitor 40mg Tablet — DRUG
    LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food

Study Details

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.

Key Dates

Start date
Sep 19, 2022
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-HER2 targeted therapy + Lipitor 40mg daily
    Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

Primary Outcome Measure

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 [ Time Frame: Five years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Trinitas Hospital and Comprehensive Cancer CenterElizabethNew Jersey07202
Mridula George, MD
[email protected]
732-235-9081
RWJBarnabas Health - Robert Wood Johnson University Hospital, HamiltonHamiltonNew Jersey08690
Mridula George, MD
[email protected]
732-235-2465
RWJBarnabas Health - - Jersey City Medical MedicalJersey CityNew Jersey07097
mridula George, MD
[email protected]
732-235-9081
Monmouth Medical Center Southern CampusLakewoodNew Jersey08701
Mridula George, MD
[email protected]
732-235-9081
Monmouth Community MedicalLong BranchNew Jersey07764
Mridula George, MD
[email protected]
732-222-6046
RWJBarnabas Health - Monmouth Medical CenterLong BranchNew Jersey07740
Mridula George, MD
[email protected]
732 -235-9081
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Mridula George, MD
[email protected]
732-235-9081
RWJBarnabas Health - Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903
Mridula George, MD
[email protected]
732-235-9081
RWJBarnabas Health - Newark Beth Israel Medical CenterNewarkNew Jersey07112
Mridula George, MD
[email protected]
732-235-2465
RWJBarnabas Health - Robert Wood Johnson University HospitalSomersetNew Jersey08873
Mridula George, MD
[email protected]
732-235-2465

Find similar trials in Elizabeth, NJ

By research site
Trinitas Hospital and Comprehensive Cancer Center· Elizabeth, NJRWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton· Hamilton, NJRWJBarnabas Health - - Jersey City Medical Medical· Jersey City, NJMonmouth Medical Center Southern Campus· Lakewood, NJMonmouth Community Medical· Long Branch, NJRWJBarnabas Health - Monmouth Medical Center· Long Branch, NJ

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