Clinical trial NCT03971019: Survival Benefits of Statins in Breast Cancer Patients
Official title: Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer Female
Keywords: breast cancer
statins
abnormal lipid metabolism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 314
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins.
Primary purpose: TREATMENT

Brief 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 Informed consent was withdrawn or the researcher decided that the drug must be discontinued.

Eligibility criteria: 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.

Primary outcomes:
measure: DFS
timeFrame: 5 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: PUMCH
state: Beijing
Study officials:
affiliation: PUMCH
name: Xuefei Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Filippatos 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.
citation: Patnaik 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.
citation: Beckwitt 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.
citation: Liu 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.