Clinical trial · Interventional
Survival Benefits of Statins in Breast Cancer Patients
Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism
NCT03971019CI-TRIAL-00040071SBSBCunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary intervention group (control group) | Behavioral | — | UNRESOLVED |
| statins | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Statin therapy (experimental group)
- description
- On the basis of guiding patients to control their diet and improve their lifestyle, etc. Simvastatin 20mg/d QN Po (dosage can be adjusted according to the blood lipid level of each reexamination) Atorvastatin 10mg/d QN Po (patients who cannot tolerate the side effects of simvastatin may consider replacing this drug)
- interventionNames
- Drug: statins
- type
- OTHER
- label
- Dietary intervention group (control group)
- description
- Guiding patients to control diet, improve lifestyle, etc.
- interventionNames
- Behavioral: Dietary intervention group (control group)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as invasive breast cancer, it has been treated surgically, confirmed by histology, cytology or imaging. 2. Female patients (35-75 years old); 3. The low-risk patients with ASCVD are detailed in Annex 1. 4. Signed written informed consent approved by IRB or IEC Exclusion Criteria: 1. The subjects were pregnant or lactating. 2. Pregnancy test positive (urine or serum) in women with potential pregnancy within 7 days before administration. 3. Other invasive tumors (including the second primary breast cancer) may affect the evaluation of outcomes and the compliance of schemes, but subjects who have been cured and survived disease-free for at least five years can be selected. 4. Patients with chronic underlying liver diseases who have abnormal liver function and/or clinical manifestations: Serum total bilirubin \> 2.5 \*ULN; or INR \> 1.5 although there was no increase in bilirubin Serum ALT or AST \> 3 \*ULN; Alkaline phosphatase \> 2.5 \*ULN; Elevated ALT or AST may gradually recover, but with progressively increased fatigue, nausea and vomiting, fever, right upper abdominal pain or tenderness. 5. Extremely high risk ASCVD patients Including acute coronary syndrome (ACS), stable coronary heart disease, revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerosis, etc. 6. High-risk ASCVD patients (in accordance with one of the following circumstances): LDL-C\>4.9 mmol/L or TC\>7.2 mmol/L Diabetic patients with 1.8 mmol/L \< LDL-C \< 4.9 mmol/L (or) 3.1 mmol/L \< TC \< 7.2 mmol/L and age \< 40 years The 10-year risk of ASCVD was moderate and younger than 55 years old. The remaining life risk was assessed. Those with any of the following two or more risk factors are defined as high risk: Systolic or diastolic blood pressure (\> 160 mmHg) or (\> 100 mmHg) * Non-HDL-C\>5.2 mmol/L (200 mg/dl) * HDL-C \< 1.0 mmol/L (40 mg/dl) * BMI\>28 kg/m2 Smoking 7. In the abnormal group of simple TG (triglyceride), TG (\> 5.7 mmol/L) 8. Other serious diseases, including: Congestive heart failure (NYHA grade II, III, IV); dyspnea at rest or requiring oxygen therapy; severe infection; uncontrolled diabetes mellitus; 9. If there are serious mental or mental disorders, it is estimated that the subjects'compliance to participate in this study is not strong. 10. Drug allergies to research drugs are known. 11. Participated in other drug clinical trials in the past 30 days. 12. Failure to complete at least one cycle of clinical trials based on this protocol, and failure to evaluate safety and effectiveness. 13. Serious violation of this study program, not in accordance with the prescribed dose, method and course of treatment.
References
Publications (4)
- BACKGROUNDFilippatos TD, Liberopoulos EN, Pavlidis N, Elisaf MS, Mikhailidis DP. Effects of hormonal treatment on lipids in patients with cancer. Cancer Treat Rev. 2009 Apr;35(2):175-84. doi: 10.1016/j.ctrv.2008.09.007. Epub 2008 Nov 14. PMID 19013720
- RESULTPatnaik JL, Byers T, DiGuiseppi C, Dabelea D, Denberg TD. Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study. Breast Cancer Res. 2011 Jun 20;13(3):R64. doi: 10.1186/bcr2901. PMID 21689398
- RESULTBeckwitt CH, Brufsky A, Oltvai ZN, Wells A. Statin drugs to reduce breast cancer recurrence and mortality. Breast Cancer Res. 2018 Nov 20;20(1):144. doi: 10.1186/s13058-018-1066-z. PMID 30458856
- RESULTLiu B, Yi Z, Guan X, Zeng YX, Ma F. The relationship between statins and breast cancer prognosis varies by statin type and exposure time: a meta-analysis. Breast Cancer Res Treat. 2017 Jul;164(1):1-11. doi: 10.1007/s10549-017-4246-0. Epub 2017 Apr 21. PMID 28432513