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Closed due to low accrual
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| Name | Class |
|---|---|
| California Breast Cancer Research Program | OTHER |
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The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Agent | Experimental | One atorvastatin 20 mg oral capsule per day |
|
| Control | Placebo Comparator | One matching placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI) | baseline to 12 months post initiation of statin intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Longitudinal Strain as Measured by CMRI | Baseline to 12 months of follow-up | |
| Change in Peak Left Ventricular Twist as Measured by CMRI | Baseline to 12 months of follow-up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Goodman, PhD | Cedars-Sinal Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Agent | One atorvastatin 20 mg oral capsule per day Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. |
| FG001 | Control | One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Agent | One atorvastatin 20 mg oral capsule per day Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI) | As accrual fell well below target, change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) was not calculated. | Posted | baseline to 12 months post initiation of statin intervention |
|
Adverse events were collected over the 12-month intervention period and within 30 days of the last administration of the study drug.
Regular investigator assessment, regular laboratory testing, self-reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Agent | One atorvastatin 20 mg oral capsule per day Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
Accrual fell well below target. Two subjects were randomized to the study and one subject completed the study. Outcome measures were not analyzed due to insufficient accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Goodman, PhD | Cedars-Sinai Medical Center | 310-423-6188 | Marc.Goodman@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2017 | Mar 25, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2018 | Mar 25, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006331 | Heart Diseases |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | A substance that has no therapeutic effect, and will be used as a control in testing the study agent. |
|
| Change in Peak Left Ventricular Torsion as Measured by CMRI |
| Baseline to 12 months of follow-up |
| Change in Left Ventricular Untwisting Rate as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Left Ventricular Ejection Fraction as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Left Ventricular End Diastolic Volume as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Left Ventricular End Systolic Volume as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Cardiac Output as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Left Ventricular Mass as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Left Ventricular Concentricity as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Native T1 as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Post Contrast T1 as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Extracellular Volume as Measured by CMRI | Baseline to 12 months of follow-up |
| Change in Native T2 as Measured by CMRI | Baseline to 12 months of follow-up |
| Control |
One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Change in Global Longitudinal Strain as Measured by CMRI | As accrual fell well below target, change in global longitudinal strain as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Peak Left Ventricular Twist as Measured by CMRI | As accrual fell well below target, change in peak left ventricular twist as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Peak Left Ventricular Torsion as Measured by CMRI | As accrual fell well below target, change in peak left ventricular torsion as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular Untwisting Rate as Measured by CMRI | As accrual fell well below target, change in left ventricular untwisting rate as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular Ejection Fraction as Measured by CMRI | As accrual fell well below target, change in left ventricular ejection fraction as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular End Diastolic Volume as Measured by CMRI | As accrual fell well below target, change in left ventricular end diastolic volume as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular End Systolic Volume as Measured by CMRI | As accrual fell well below target, change in left ventricular end systolic volume as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Cardiac Output as Measured by CMRI | As accrual fell well below target, change in cardiac output as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular Mass as Measured by CMRI | As accrual fell well below target, change in left ventricular mass as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Left Ventricular Concentricity as Measured by CMRI | As accrual fell well below target, change in left ventricular concentricity as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Native T1 as Measured by CMRI | As accrual fell well below target, change in native T1 as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Post Contrast T1 as Measured by CMRI | As accrual fell well below target, change in post contrast T1 as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Extracellular Volume as Measured by CMRI | As accrual fell well below target, change in extracellular volume as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| Secondary | Change in Native T2 as Measured by CMRI | As accrual fell well below target, change in native T2 as measured by CMRI was not calculated. | Posted | Baseline to 12 months of follow-up |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Control | One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent. | 0 | 1 | 1 | 1 | 1 | 1 |
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| abdominal cramping | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| hot flashes | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| mood changes | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| vitamin D deficiency | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |