Cardiac Toxicity, Early-stage Breast Cancer
Conditions
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.
Interventions
DRUGLipitor 40mg Tablet
LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactMridula George, MD
Backup ContactCoral Omene, MD
Outcome results
None listed