Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Early-stage Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559164
• Other study ID #: 042201
• Secondary ID: Pro2022000290
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2022
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Mridula George, MD
• Phone: 732-235-9081
• Email: mridula[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Toxicity
• Cardiotoxicity
• Early-stage Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Trinitas Hospital and Comprehensive Cancer Center	Elizabeth	New Jersey
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton	Hamilton	New Jersey
United States	RWJBarnabas Health - - Jersey City Medical Medical	Jersey City	New Jersey
United States	Monmouth Medical Center Southern Campus	Lakewood	New Jersey
United States	Monmouth Community Medical	Long Branch	New Jersey
United States	RWJBarnabas Health - Monmouth Medical Center	Long Branch	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	RWJBarnabas Health - Newark Beth Israel Medical Center	Newark	New Jersey
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	Somerset	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months	Baseline, six, twelve and fifteen months
Other	Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure physical functioning	Baseline, six, twelve and fifteen months
Other	Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure emotional distress	Baseline, six, twelve and fifteen months
Other	Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure social participation	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure social participation	Baseline, six, twelve and fifteen months
Primary	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	Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years	Five years
Secondary	Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain	Quality of Life questionnaire using PROMIS will be administered at baseline, six, twelve and fifteen months	Baseline, six, twelve and fifteen months