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Survival Benefits of Statins in Breast Cancer Patients (SBSBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971019
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: statins Behavioral: Dietary intervention group (control group) Phase 3

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 Informed consent was withdrawn or the researcher decided that the drug must be discontinued.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : May 28, 2024
Estimated Study Completion Date : June 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Statin therapy (experimental group)

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
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).
Other Names:
  • 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

Dietary intervention group (control group)
Guiding patients to control diet, improve lifestyle, etc.
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
Other Name: Dietary and motor regulation




Primary Outcome Measures :
  1. DFS [ Time Frame: 5 years ]
    Disease free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 5 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female breast cancer patients
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971019


Contacts
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Contact: Xuefei Wang, M.D. 008613001289600 1210548954@qq.com
Contact: Qiang Sun, M.D. 008618801038718 799692578@qq.com

Locations
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China, Beijing
PUMCH Recruiting
Beijing, Beijing, China, 100730
Contact: Xu Hui, M.D.    0086-13810399955    pumchkyc@126.com   
Principal Investigator: Xuefei Wang, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Xuefei Wang, M.D. PUMCH
  Study Documents (Full-Text)

Documents provided by Peking Union Medical College Hospital:

Publications of Results:
Other Publications:
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03971019    
Other Study ID Numbers: PUMCH-SBSBC
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results of this study can be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
breast cancer
statins
abnormal lipid metabolism
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Calcium, Dietary
Atorvastatin
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors