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New treatment option for Cardiac Toxicity
Official title Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
ClinicalTrials.gov ID: NCT05559164
What this study is testing
What is Lipitor 40mg Tablet?
Lipitor 40mg Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cardiac toxicity.
Also referred to as Atorvastatin Calcium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Baseline LVEF ≥ 50%
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Elizabeth, New Jersey, United States
- Hamilton, New Jersey, United States
- Jersey City, New Jersey, United States
- Lakewood, New Jersey, United States
- Long Branch, New Jersey, United States
- New Brunswick, New Jersey, United States
- Newark, New Jersey, United States
- Somerset, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elizabeth, New Jersey, United States; Hamilton, New Jersey, United States; Jersey City, New Jersey, United States; Lakewood, New Jersey, United States; Long Branch, New Jersey, United States; New Brunswick, New Jersey, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.