Clinical trial NCT05559164: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Official title: STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiac Toxicity
Early-stage Breast Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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.

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

Primary outcomes:
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
timeFrame: Five years
Secondary outcomes:
measure: Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain
timeFrame: Baseline, six, twelve and fifteen months
Other outcomes:
measure: Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue
timeFrame: Baseline, six, twelve and fifteen months
measure: Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning
timeFrame: Baseline, six, twelve and fifteen months
measure: Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress
timeFrame: Baseline, six, twelve and fifteen months
measure: Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure social participation
timeFrame: Baseline, six, twelve and fifteen months
Locations:
city: Elizabeth
country: United States
facility: Trinitas Hospital and Comprehensive Cancer Center
state: New Jersey
city: Hamilton
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
state: New Jersey
city: Jersey City
country: United States
facility: RWJBarnabas Health - - Jersey City Medical Medical
state: New Jersey
city: Lakewood
country: United States
facility: Monmouth Medical Center Southern Campus
state: New Jersey
city: Long Branch
country: United States
facility: RWJBarnabas Health - Monmouth Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Community Medical
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: Newark
country: United States
facility: RWJBarnabas Health - Newark Beth Israel Medical Center
state: New Jersey
city: Somerset
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Mridula George, MD
role: PRINCIPAL_INVESTIGATOR
References: