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Breast Cancer FemalePhase 3SBSBCNCT03971019

Survival Benefits of Statins in Breast Cancer Patients

A Phase 3 study testing statins in people with Breast Cancer Female, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
statins
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteChina
Study dates
28 Mar 2019to 28 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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:
  • Congestive heart failure (NYHA grade II, III, IV); dyspnea at rest or requiring oxygen therapy; severe infection; uncontrolled diabetes mellitus;
  • If there are serious mental or mental disorders, it is estimated that the subjects'compliance to participate in this study is not strong.
  • Drug allergies to research drugs are known.
  • Participated in other drug clinical trials in the past 30 days.
  • Failure to complete at least one cycle of clinical trials based on this protocol, and failure to evaluate safety and effectiveness.
  • Serious violation of this study program, not in accordance with the prescribed dose, method and course of treatment.

Trial locations and contacts

1 site in 1 country.

Xuefei Wang, M.D. contact

008613001289600

1210548954@qq.com

Qiang Sun, M.D. contact

008618801038718

799692578@qq.com

China1 site, 1 recruiting

  • PUMCH

    Beijing, Beijing Municipality, 100730

    Xu Hui, M.D., 0086-13810399955, pumchkyc@126.com

    Xuefei Wang, M.D.

    Recruiting

Other trials in China

About this study

Official title: Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism

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.

Read the 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.

Being tested
statins, Dietary intervention group (control group)
Keywords
breast cancer, statins, abnormal lipid metabolism
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • statinsDrug

    Also called 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

    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).

  • Dietary intervention group (control group)Behavioural

    Also called Dietary and motor regulation

    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

Study groups in NCT03971019
Study groupRoleWhat they receive
Statin therapy (experimental group)ExperimentalOn 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)
Receives: Drug: statins
Dietary intervention group (control group)OtherGuiding patients to control diet, improve lifestyle, etc.
Receives: Behavioral: Dietary intervention group (control group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS

    Disease free survival

    Measured: 5 years

Secondary outcomes (1)

  1. OS

    Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start28 Mar 2019
  3. Primary completion28 May 2024 (estimated)
  4. Study completion28 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins.
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971019
Sponsor's protocol ID
PUMCH-SBSBC
Acronym
SBSBC
Status last verified
Aug 2019
First submitted
30 Mar 2019
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of this study can be shared

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.

    PubMed 19013720

  • 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.

    PubMed 21689398

  • 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.

    PubMed 30458856

  • 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.

    PubMed 28432513

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing statins in people with Breast Cancer Female, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xuefei Wang, M.D. (008613001289600, 1210548954@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03971019, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

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