Survival Benefits of Statins in Breast Cancer Patients

NCT03971019 | Unknown Phase 3 DMC

• 1 other identifier: PUMCH-SBSBC
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

breast cancer; statins; abnormal lipid metabolism

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival

  5 years

Secondary Outcomes (1)

• OS

  5 years

Study Arms (2)

Statin therapy (experimental group)

EXPERIMENTAL

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)

Drug: statins

Dietary intervention group (control group)

OTHER

Guiding patients to control diet, improve lifestyle, etc.

Behavioral: Dietary intervention group (control group)

Interventions

statins DRUG

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).

Also known as: Simvastatin Shu Jiangzhi is manufactured by Merchant Company20mg*14 tablets Dose group: 20 mg once a day before bed, Atorvastatin Lipitor, commonly known as Atorvastatin Calcium Tablets, 20mg*7 tablets Dose group: 10 mg once a day before bed, Atorvastatin Ale Beijing Jialin Pharmaceutical Co., Ltd. Alatorvastatin Calcium Tablets Specification and packing: 10mg*7 tablets Dose group: 10 mg once a day before bed

Statin therapy (experimental group)

Dietary intervention group (control group) BEHAVIORAL

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

Also known as: Dietary and motor regulation

Dietary intervention group (control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as invasive breast cancer, it has been treated surgically, confirmed by histology, cytology or imaging.
• Female patients (35-75 years old);
• The low-risk patients with ASCVD are detailed in Annex 1.
• Signed written informed consent approved by IRB or IEC

You may not qualify if:

• The subjects were pregnant or lactating.
• Pregnancy test positive (urine or serum) in women with potential pregnancy within 7 days before administration.
• 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.
• 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.
• 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.
• 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
• In the abnormal group of simple TG (triglyceride), TG (\> 5.7 mmol/L)
• Other serious diseases, including:

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

PUMCH

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 19013720 BACKGROUND

• 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.

  PMID: 21689398 RESULT

• 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.

  PMID: 30458856 RESULT

• 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.

  PMID: 28432513 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Control Groups; Diet

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Xuefei Wang, M.D.

  PUMCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefei Wang, M.D.

CONTACT

008613001289600; 1210548954@qq.com

Qiang Sun, M.D.

CONTACT

008618801038718; 799692578@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins.

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: June 3, 2019
• Study Start: March 28, 2019
• Primary Completion: May 28, 2024
• Study Completion: June 28, 2024
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)