Breast CancerPhase 2NCT01988571
Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Lymphoma, run by Wake Forest University Health Sciences at 51 sites in United States.
Trial summary
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 individuals receiving adjuvant anthracycline-based chemotherapy for breast cancer of lymphoma. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Breast Cancer, Lymphoma
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 51 sitesUnited States
- Study dates
- 1 Feb 2014to 24 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma Stage I-IV. (Patients should have a > 2 year life expectancy)
- Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)
- 21 years of age or older
- LVEF > 50% (Most recent within the last 5 years)
- Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment
- Patients that are receiving or have received chemotherapy regimens are allowed
Show all 9Show fewer
- Able to hold breath for 10 seconds
- Prior cancers allowed if no evidence of disease in last 5 years
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Who cannot join
- 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
Show all 15Show fewer
- 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;pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
- Unstable angina; significant ventricular arrhythmias (>20 premature ventricular complexes (PVCs)/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response; coronary artery disease; acute myocardial infarction within 28 days
- Current use of Cytochrome P450 (CYP3A4) 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
- Claustrophobia
- Planning to move within 24 months of trial enrollment
- Pregnant or breast-feeding
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Mission Hospital
Asheville, North Carolina, 28801
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816
Tufts Medical Center
Boston, Massachusetts, 02111
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Medical University of South Carolina
Charleston, South Carolina, 29425
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Doctors Hospital
Columbus, Ohio, 43228
Geisinger Medical Center
Danville, Pennsylvania, 17822
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078
Southern Oncology Specialists-Huntersville
Huntersville, North Carolina, 28078
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, 24501
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Novant Health Cancer Specialists-Matthews
Matthews, North Carolina, 28105
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Virginia Cancer Institute
Richmond, Virginia, 23230
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
William Beaumont Hospital - Troy
Troy, Michigan, 48085
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Shenandoah Oncology PC
Winchester, Virginia, 22601
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
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 individuals receiving adjuvant anthracycline-based chemotherapy for breast cancer of lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
Specific Aim 1:
To determine if Atorvastatin(Lipitor) administration preserves left ventricular ejection fraction (LVEF) 24 months after initiation of Anthracycline-based adjuvant therapy for adjuvant treatment of breast cancer or lymphoma.
Specific Aim 2:
To determine if baseline to 6-month differences in LVEF predict baseline to 24-month differences in LVEF after Anthracycline-based adjuvant therapy and concomitant atorvastatin therapy.
To achieve these aims, we will perform a double-blind, placebo-controlled, randomized clinical trial of 0 or 40 mg of atorvastatin/day in 278 individuals scheduled to receive Anthracycline-based chemotherapy for treatment of Stage I-III breast cancer or lymphoma Stage I-IV with a projected > 2 year life expectancy. We will use innovative noninvasive magnetic resonance imaging (MRI) procedures to accurately measure LVEF. In addition, we will measure left ventricle (LV) volumes, myocardial strain, fibrosis, aortic pulse wave velocity (PWV) and wall thickness, all factors that can influence LVEF by altering LV pre-load, after-load, and contractility.19,20 Advanced serum biomarkers will be measured that assess for the presence of oxidative/nitrosative stress, systemic inflammation and circulating neurohormones that also may influence LVEF.
This study will test a new clinical paradigm to manage breast cancer: primary prevention of Anthracycline-based adjuvant therapy-related LV dysfunction using pre-treatment with low-cost statins. In addition, this trial will be the first systematic collection of data regarding the mechanism(s) and time course by which LV dysfunction and subsequent chronic heart failure (CHF) evolve in individuals given Anthracycline-based chemotherapy for breast cancer or lymphoma. These data will be useful to physicians trying to determine the optimal cardiac protection strategies when administering adjuvant chemotherapeutic regimens to their breast cancer or lymphoma patients. The objective of this research is to use inexpensive medications to preserve cardiovascular (CV) health and thereby improve overall survival in the growing number of breast cancer and lymphoma patients.
SECONDARY OBJECTIVES
Specific Aim 1:
To document the effect of Atorvastatin (Lipitor) on cognitive function using a battery of neurocognitive tests (HVLT, Rey-osterrieth Figure, controlled oral word association test (COWA), Trail-making Parts A and B, Digit Span and Grooved Pegboard) in breast cancer and lymphoma patients receiving an anthracycline.
Specific Aim 2:
To document the effect of Atorvastatin(Lipitor) on self-reported quality of life using validated questionnaires (PROMIS including: General form, Cog Concerns, Cog Abilities, Fatigue, Pain intensity and interference, Sleep Disturbance, Physical Functioning and Social Functioning) in breast cancer and lymphoma patients receiving an anthracycline.
- Conditions
- Breast Cancer, Lymphoma
- Being tested
- Atorvastatin, Placebo
- Keywords
- Stage I breast cancer, Stage II breast cancer, Stage III breast cancer, Stage I Lymphoma, Stage II Lymphoma, Stage III Lymphoma, Stage IV Lymphoma
- Medical subject headings
- Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
40 mg tablet taken by mouth each morning for 24 months.
PlaceboDrug
Also called sugar pill
One placebo tablet taken each morning orally for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Atorvastatin | Active comparator | One 40 mg Atorvastatin tablet each morning by mouth for 24 months Receives: Drug: Atorvastatin |
| Arm 2 - Placebo | Placebo comparator | One placebo tablet each morning by mouth for 24 months. Receives: Drug: Atorvastatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
Secondary outcomes (9)
End Diastolic Volume
24 month estimated values of clinical measurements obtained from Cardiac MRI End Diastolic Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
End Systolic Volume
24 month estimated values of clinical measurements obtained from Cardiac MRI End Systolic Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
Stroke Volume
24 month estimated values of clinical measurements obtained from Cardiac MRI Stroke Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
Left Ventricular (LV) Mass
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular mass by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
Pulse Wave Velocity
24 month estimated values of clinical measurements obtained from Cardiac MRI pulse wave velocity by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Measured: 24 months
Hopkins Verbal Learning Test (HVLT) Total Recall
24 month estimated values Hopkins Verbal Learning test (HVLT) total recall by group. Linear model adjusts for baseline value and group assignment. No missing imputation performed. Ranges from 0 to 36 and higher numbers reflect better recall.
Measured: 24 months
Controlled Oral Word Association (COWA)
24 month estimated values Controlled Oral Word Association (COWA) by group. Linear model adjusts for baseline value and group assignment. No missing imputation performed. The COWA uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 min to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. Ranges from 0 to the total number of correct words that begin with one of the letters in the set. There is no ceiling of a maximum score. Higher numbers reflect better verbal fluency.
Measured: 24 months
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Applied Cognition - General Concerns - Short Form 4a
Patient reported quality of life outcomes obtained from patient-reported outcomes measurement (PROMIS) questionnaire - Applied Cognition - General Concerns - Short Form 4a . Scores range from 4-20 and then adjusted by t-scores ranging from 30.1-63.8. Higher scores reflect better cognition. Linear models include baseline assessment and group and multiple imputation was utilized.
Measured: 24 months
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Fatigue Short Form 41
Patient reported quality of life outcomes obtained from patient-reported outcomes measurement (PROMIS) questionnaire - Fatigue Short Form 41. Scores range from 4-20 and then adjusted by t-scores ranging from 33.7-75.8. Higher scores reflect worse fatigue. Linear models include baseline assessment and group and multiple imputation was utilized.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start1 Feb 2014
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Hundley, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988571
- Sponsor's protocol ID
- IRB00038639
- Other IDs
- U10CA081851, 1R01HL118740-01, REBACCCWFU 98213, NCI-2013-01760
- Status last verified
- Dec 2021
- First submitted
- 1 Nov 2013
- Last updated
- 4 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Grizzard PJ, O'Connell NS, Rapp SR, Olson KC, Bellissimo MP, Hughes AN, Ladd AC, Weaver KE, Wagner LI, Ruddy KJ, Ky B, D'Agostino RB, Hundley WG. Preserved Cognitive Function After Statin Administration During Cancer Treatment With Doxorubicin: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538325. doi: 10.1001/jamanetworkopen.2025.38325.
PubMed 41118164Sutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardiooncology. 2025 Feb 5;11(1):11. doi: 10.1186/s40959-025-00311-y.
PubMed 39910652Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM Evid. 2022 Sep;1(9):10.1056/evidoa2200097. doi: 10.1056/evidoa2200097. Epub 2022 Aug 18.
PubMed 36908314
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
- ClinicalTrials.gov ID
- NCT01988571
- Acronym / sponsor ID
- IRB00038639
- Conditions
- Breast Cancer, Lymphoma
- Keywords
- Stage I breast cancer, Stage II breast cancer, Stage III breast cancer, Stage I Lymphoma, Stage II Lymphoma, Stage III Lymphoma, Stage IV Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 4 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 individuals receiving adjuvant anthracycline-based chemotherapy for breast cancer of lymphoma.
Detailed description
PRIMARY OBJECTIVES:
Specific Aim 1:
To determine if Atorvastatin(Lipitor) administration preserves left ventricular ejection fraction (LVEF) 24 months after initiation of Anthracycline-based adjuvant therapy for adjuvant treatment of breast cancer or lymphoma.
Specific Aim 2:
To determine if baseline to 6-month differences in LVEF predict baseline to 24-month differences in LVEF after Anthracycline-based adjuvant therapy and concomitant atorvastatin therapy.
To achieve these aims, we will perform a double-blind, placebo-controlled, randomized clinical trial of 0 or 40 mg of atorvastatin/day in 278 individuals scheduled to receive Anthracycline-based chemotherapy for treatment of Stage I-III breast cancer or lymphoma Stage I-IV with a projected > 2 year life expectancy. We will use innovative noninvasive magnetic resonance imaging (MRI) procedures to accurately measure LVEF. In addition, we will measure left ventricle (LV) volumes, myocardial strain, fibrosis, aortic pulse wave velocity (PWV) and wall thickness, all factors that can influence LVEF by altering LV pre-load, after-load, and contractility.19,20 Advanced serum biomarkers will be measured that assess for the presence of oxidative/nitrosative stress, systemic inflammation and circulating neurohormones that also may influence LVEF.
This study will test a new clinical paradigm to manage breast cancer: primary prevention of Anthracycline-based adjuvant therapy-related LV dysfunction using pre-treatment with low-cost statins. In addition, this trial will be the first systematic collection of data regarding the mechanism(s) and time course by which LV dysfunction and subsequent chronic heart failure (CHF) evolve in individuals given Anthracycline-based chemotherapy for breast cancer or lymphoma. These data will be useful to physicians trying to determine the optimal cardiac protection strategies when administering adjuvant chemotherapeutic regimens to their breast cancer or lymphoma patients. The objective of this research is to use inexpensive medications to preserve cardiovascular (CV) health and thereby improve overall survival in the growing number of breast cancer and lymphoma patients.
SECONDARY OBJECTIVES
Specific Aim 1:
To document the effect of Atorvastatin (Lipitor) on cognitive function using a battery of neurocognitive tests (HVLT, Rey-osterrieth Figure, controlled oral word association test (COWA), Trail-making Parts A and B, Digit Span and Grooved Pegboard) in breast cancer and lymphoma patients receiving an anthracycline.
Specific Aim 2:
To document the effect of Atorvastatin(Lipitor) on self-reported quality of life using validated questionnaires (PROMIS including: General form, Cog Concerns, Cog Abilities, Fatigue, Pain intensity and interference, Sleep Disturbance, Physical Functioning and Social Functioning) in breast cancer and lymphoma patients receiving an anthracycline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Atorvastatin | Active comparator | Drug: AtorvastatinOne 40 mg Atorvastatin tablet each morning by mouth for 24 months |
| Arm 2 - Placebo | Placebo comparator | Drug: Atorvastatin, Drug: PlaceboOne placebo tablet each morning by mouth for 24 months. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma Stage I-IV. (Patients should have a > 2 year life expectancy)
- Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)
- 21 years of age or older
- LVEF > 50% (Most recent within the last 5 years)
- Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor40 mg tablet taken by mouth each morning for 24 months. | Drug | Arm 1 - Atorvastatin, Arm 2 - Placebo |
| PlaceboAlso: sugar pillOne placebo tablet taken each morning orally for 24 months. | Drug | Arm 2 - Placebo |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: 24 months
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
9 secondary outcomes
End Diastolic Volume
Time frame: 24 months
End Systolic Volume
Time frame: 24 months
Stroke Volume
Time frame: 24 months
Left Ventricular (LV) Mass
Time frame: 24 months
Pulse Wave Velocity
Time frame: 24 months
Hopkins Verbal Learning Test (HVLT) Total Recall
Time frame: 24 months
Controlled Oral Word Association (COWA)
Time frame: 24 months
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Applied Cognition - General Concerns - Short Form 4a
Time frame: 24 months
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Fatigue Short Form 41
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41118164Grizzard PJ, O'Connell NS, Rapp SR, Olson KC, Bellissimo MP, Hughes AN, Ladd AC, Weaver KE, Wagner LI, Ruddy KJ, Ky B, D'Agostino RB, Hundley WG. Preserved Cognitive Function After Statin Administration During Cancer Treatment With Doxorubicin: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538325. doi: 10.1001/jamanetworkopen.2025.38325.
- Derived from this study: PubMed 39910652Sutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardiooncology. 2025 Feb 5;11(1):11. doi: 10.1186/s40959-025-00311-y.
- Derived from this study: PubMed 36908314Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM Evid. 2022 Sep;1(9):10.1056/evidoa2200097. doi: 10.1056/evidoa2200097. Epub 2022 Aug 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Hundley, MD principal investigator
Wake Forest University Health Sciences
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Lymphoma, run by Wake Forest University Health Sciences at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (LVEF) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988571, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.