NCT03454529

Brief Summary

The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and reduce the aggressiveness of breast cancer cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

February 22, 2018

Results QC Date

April 17, 2023

Last Update Submit

July 27, 2023

Conditions

Invasive Breast CarcinomaStage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

  • Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry

    Differences in % positive cells pre and post treatment along with 95% confidence interval

    Baseline up to 4 weeks

Other Outcomes (6)

  • Change in Percentage of Cells P27+ From Pre-treatment to Post-treatment

    Baseline up to 4 weeks

  • Cleaved Caspase-3 (CC3) as a Marker of Apoptosis

    Baseline up to 4 weeks

  • C-reactive Protein (CRP) as a Marker of Inflammation

    Baseline up to 4 weeks

  • +3 more other outcomes

Study Arms (1)

Treatment (simvastatin)

EXPERIMENTAL

Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Simvastatin

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (simvastatin)
SimvastatinDRUG

Given PO

Also known as: MK 733, Synvinolin, Zocor
Treatment (simvastatin)

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu
  • Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery
  • Performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1)
  • Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer

You may not qualify if:

  • Plans for administration of neoadjuvant chemotherapy or hormonal therapy
  • Insufficient tissue on diagnostic core breast biopsy for analysis
  • Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer)
  • Severe gastrointestinal disorder
  • Current use of statins or fibrates for any time during the 3 months prior to the study
  • Proven hypersensitivity to statins
  • White blood cell (WBC) \< 3,500/mm\^3
  • Platelet (Plt) \< 120,000/mm\^3
  • Hemoglobin (HgB) \< 10 g/dL
  • Aspartate aminotransferase (AST) \> 45 U/L
  • Alanine aminotransferase (ALT) \> 45 U/L
  • Creatinine \> 1.5 mg/dL
  • Bilirubin \> 1.15 mg/dL
  • Creatine kinase measurement (CPK) \> or = 250 mg/dL
  • Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • Asari K, Sun WT, Kok ZH, Lam YH, Ng BL, Saunders V, White DL, Chuah C, Xiang W. Simvastatin enhances the efficacy of nilotinib in chronic myeloid leukaemia by post-translational modification and drug transporter modulation. Anticancer Drugs. 2021 Jun 1;32(5):526-536. doi: 10.1097/CAD.0000000000001028.

    PMID: 33587350DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Michael Simon,MD
Organization
Karmanos Cancer Institute
simonm@karmanos.org
313. 576-8727

Study Officials

  • Michael Simon

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 6, 2018

Study Start

March 9, 2018

Primary Completion

October 6, 2021

Study Completion

October 6, 2021

Last Updated

August 1, 2023

Results First Posted

August 1, 2023

Record last verified: 2023-07

Locations

US(1)