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出境医 / 临床实验 / Survival Benefits of Statins in Breast Cancer Patients (SBSBC)

Survival Benefits of Statins in Breast Cancer Patients (SBSBC)

Study Description
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 Informed consent was withdrawn or the researcher decided that the drug must be discontinued.
Study Design
Layout table for study information
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
Arms and Interventions
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

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


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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xuefei Wang, M.D. 008613001289600 1210548954@qq.com
Contact: Qiang Sun, M.D. 008618801038718 799692578@qq.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Xuefei Wang, M.D. PUMCH
Tracking Information
First Submitted Date  ICMJE March 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date May 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
DFS [ Time Frame: 5 years ]
Disease free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
OS [ Time Frame: 5 years ]
Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survival Benefits of Statins in Breast Cancer Patients
Official Title  ICMJE Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Breast Cancer Female
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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)

    Intervention: Drug: statins
  • Dietary intervention group (control group)
    Guiding patients to control diet, improve lifestyle, etc.
    Intervention: Behavioral: Dietary intervention group (control group)
Publications *
  • 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. Review.
  • 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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
314
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2024
Estimated Primary Completion Date May 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female breast cancer patients
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xuefei Wang, M.D. 008613001289600 1210548954@qq.com
Contact: Qiang Sun, M.D. 008618801038718 799692578@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971019
Other Study ID Numbers  ICMJE PUMCH-SBSBC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The results of this study can be shared
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xuefei Wang, M.D. PUMCH
PRS Account Peking Union Medical College Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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