NCT03971019

Survival Benefits of Statins in Breast Cancer Patients

Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, we compared the survival benefit of breast cancer patients with dyslipidemia (low and medium risk of ASCVD). The control group used dietary intervention instead of statins intervention. The main endpoint was 5 years DFS. The subjects were breast cancer patients.

Detailed description

A randomized, open, blank controlled, single-center clinical trial was conducted to compare the survival benefits of statins in breast cancer patients with dyslipidemia (low and medium risk of ASCVD). The control group used dietary intervention instead of statins. The main endpoint was 3 and 5 years DFS. The subjects were breast cancer patients. In this study, 348 patients were randomly divided into two groups according to patients' wishes and written informed consent. The experimental group: control group = 1:1. Subjects were screened and administered continuously until the disease progressed and the toxicity was intolerable. Informed consent was withdrawn or the researcher decided that the drug must be discontinued.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	statins	On the basis of dietary intervention. Simvastatin 20mg/d QN Po (half an hour before bedtime) (dosage can be adjusted according to other indicators of blood lipid level in each review), atorvastatin 10mg/d QN Po (half an hour before bedtime) (patients who can not tolerate the side effects of simvastatin can consider replacing this drug).
BEHAVIORAL	Dietary intervention group (control group)	Restriction of dietary components that increase LDL-C Saturated Fatty Acids Less than 7% of total energy Dietary cholesterol \< 300 mg/d Increasing Dietary Ingredients for Reducing LDL-C Phytosterol 2\~3 g/d Water soluble dietary fiber 10\~25 g/d total energy Adjusted to maintain ideal weight or lose weight Physical activity Maintain moderate intensity exercise and consume at least 200 kcal of calories per day

Timeline

• Start date: 2019-03-28
• Primary completion: 2024-05-28
• Completion: 2024-06-28
• First posted: 2019-06-03
• Last updated: 2019-08-14

Locations

1 site across 1 country: China