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Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Suspended
CT.gov ID
NCT05559164
Collaborator
(none)
60
Enrollment
10
Locations
1
Arm
51
Anticipated Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lipitor 40mg Tablet
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
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 dailyStage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will receive Lipitor 40 mg PO daily. Anti-HER2 targeted therapy + Lipitor 40mg daily
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
Anticipated Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anti-HER2 targeted therapy + Lipitor 40mg daily

Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

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
Other Names:
  • Atorvastatin Calcium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Five years]

      Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years

    Secondary Outcome Measures

    1. Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain [Baseline, six, twelve and fifteen months]

      Quality of Life questionnaire using PROMIS will be administered at baseline, six, twelve and fifteen months

    Other Outcome Measures

    1. Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue [Baseline, six, twelve and fifteen months]

      Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months

    2. Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning [Baseline, six, twelve and fifteen months]

      Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure physical functioning

    3. Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress [Baseline, six, twelve and fifteen months]

      Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure emotional distress

    4. Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure social participation [Baseline, six, twelve and fifteen months]

      Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure social participation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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:

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trinitas Hospital and Comprehensive Cancer Center Elizabeth New Jersey United States 07202
    2 RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton Hamilton New Jersey United States 08690
    3 RWJBarnabas Health - - Jersey City Medical Medical Jersey City New Jersey United States 07097
    4 RWJBarnabas Health - Monmouth Medical Center Southern Campus Lakewood New Jersey United States 08701
    5 RWJBarnabas Health - Saint Barnabas Medical Center Livingston New Jersey United States 07039
    6 RWJBarnabas Health - Monmouth Medical Center Long Branch New Jersey United States 07740
    7 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    8 RWJBarnabas Health - Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    9 RWJBarnabas Health - Newark Beth Israel Medical Center Newark New Jersey United States 07112
    10 RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset New Jersey United States 08873

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey

    Investigators

    • Principal Investigator: Mridula George, MD, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mridula George, MD, Assistant Professor of Medicine, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT05559164
    Other Study ID Numbers:
    • CINJ042201
    • Pro2022000290
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Oct 7, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Cardiotoxicity
    Atorvastatin

    Study Results

    No Results Posted as of Oct 7, 2022