Preventing Anthracycline Cardiovascular Toxicity with Statins (PREVENT)
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 15-007832
NCT ID: NCT01988571
Sponsor Protocol Number: WF 98213
About this study
The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in women who are receiving anthracycline-based chemotherapy for breast cancer.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Newly diagnosed Stage I-III female breast cancer including inflammatory breast cancer
- Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)
- 30 to 80 years of age
- LVEF > 50% (Most recent within the last 5 years)
- Prior chemotherapy regimen not containing anthracyclines is allowed
- Able to hold breath for 15 seconds
- Prior cancers allowed if no evidence of disease in last 5 years
- ECOG 0 or 1
- Prior use of lipid-lowering therapy within the last 6 months
- Current postmenopausal hormone-replacement therapy
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- Scheduled to receive neoadjuvant chemotherapy with an anthracycline
- No active liver disease allowed
- Uncontrolled hypothyroidism
- Recent history (within past 3 years) of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, use of immunosuppressant agents, or another medical condition that might compromise safety or the successful completion of the study
- Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal such as pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
- Unstable angina, significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response, coronary artery disease, or acute myocardial infarction within 28 days
- Current use of CYP 3A4 inhibitors. These include Clarithromycin, HIV protease inhibitors, Itraconazole, grapefruit juice, Cyclosporine, Rifampin or Digoxin
- Current or history of hepatic dysfunction
- Unable to provide informed consent
- Planning to move within 24 months of trial enrollment
- Pregnant or breast-feeding
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Kathryn Ruddy, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office