Trial Outcomes & Findings for STOP Heart Disease in Breast Cancer Survivors Trial (NCT NCT02674204)

NCT ID: NCT02674204

Last Updated: 2019-05-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: baseline to 12 months post initiation of statin intervention
• Results posted on: 2019-05-15

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	1	0

Baseline Characteristics

STOP Heart Disease in Breast Cancer Survivors Trial

Baseline characteristics by cohort

Measure	Study Agent n=1 Participants 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.	Control n=1 Participants One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 months post initiation of statin intervention

Population: As accrual fell well below target, change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in global longitudinal strain as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in peak left ventricular twist as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in peak left ventricular torsion as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular untwisting rate as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular ejection fraction as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular end diastolic volume as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular end systolic volume as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in cardiac output as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular mass as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in left ventricular concentricity as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in native T1 as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in post contrast T1 as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in extracellular volume as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months of follow-up

Population: As accrual fell well below target, change in native T2 as measured by CMRI was not calculated.

Outcome measures

Outcome data not reported

Adverse Events

Study Agent

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Agent n=1 participants at risk 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.	Control n=1 participants at risk One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Gastrointestinal disorders colitis	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders diarrhea	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.

Other adverse events

Measure	Study Agent n=1 participants at risk 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.	Control n=1 participants at risk One matching placebo daily Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Investigations alanine aminotransferase increased	100.0% 1/1 • Number of events 2 • 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.	0.00% 0/1 • 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.
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 3 • 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.
Investigations aspartate aminotransferase increased	100.0% 1/1 • Number of events 1 • 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.	0.00% 0/1 • 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.
Musculoskeletal and connective tissue disorders myalgia	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders nausea	100.0% 1/1 • Number of events 1 • 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.	100.0% 1/1 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders pain in extremity	100.0% 1/1 • Number of events 1 • 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.	0.00% 0/1 • 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.
Psychiatric disorders insomnia	100.0% 1/1 • Number of events 1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders dyspepsia	100.0% 1/1 • Number of events 1 • 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.	0.00% 0/1 • 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.
Gastrointestinal disorders vomiting	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 2 • 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.
Nervous system disorders neuralgia	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders abdominal cramping	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
General disorders fatigue	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
General disorders pain	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Reproductive system and breast disorders hot flashes	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders dizziness	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 2 • 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.
Psychiatric disorders mood changes	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Infections and infestations upper respiratory tract infection	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Infections and infestations abdominal infection	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
General disorders vitamin D deficiency	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders osteoporosis	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders somnolence	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders diarrhea	0.00% 0/1 • 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.	100.0% 1/1 • Number of events 1 • 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.

Additional Information

Marc Goodman, PhD

Cedars-Sinai Medical Center

Phone: 310-423-6188

Email: Marc.Goodman@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place