Trial Title:
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
NCT ID:
NCT05559164
Condition:
Cardiac Toxicity
Early-stage Breast Cancer
Conditions: Official terms:
Cardiotoxicity
Atorvastatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Stage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will
receive Lipitor 40 mg PO daily.
Anti-HER2 targeted therapy + Lipitor 40mg daily
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lipitor 40mg Tablet
Description:
LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of
40 mg once daily, with or without food
Arm group label:
Anti-HER2 targeted therapy + Lipitor 40mg daily
Other name:
Atorvastatin Calcium
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.
Detailed description:
A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins
in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy.
This study will evaluate the hypothesis that addition of statins will reduce treatment
delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in
patients being treated with anti-HER2 therapy. The long-term goal of this study is to
improve disease related outcomes and quality of life measures in patients being treated
with anti-HER2 therapy.
Criteria for eligibility:
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
Gender:
Female
Gender based:
Yes
Gender description:
• 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.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Trinitas Hospital and Comprehensive Cancer Center
Address:
City:
Elizabeth
Zip:
07202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Address:
City:
Hamilton
Zip:
08690
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-2465
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - - Jersey City Medical Medical
Address:
City:
Jersey City
Zip:
07097
Country:
United States
Status:
Recruiting
Contact:
Last name:
mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
Monmouth Medical Center Southern Campus
Address:
City:
Lakewood
Zip:
08701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Monmouth Medical Center
Address:
City:
Long Branch
Zip:
07740
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
Monmouth Community Medical
Address:
City:
Long Branch
Zip:
07764
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-222-6046
Email:
mridula@CINJ.rutgers.edu
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-2465
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
Somerset
Zip:
08873
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula George, MD
Phone:
732-235-2465
Email:
mridula@cinj.rutgers.edu
Start date:
September 19, 2022
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559164
