NCT00807950

Brief Summary

We hypothesize that Simvastatin administration would result in selective killing of the basal subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We further hypothesize that tumor genomic changes would correlate with tumor response to Simvastatin. We are also looking to correlate Simvastatin biological effects with the expression pattern of initial status of primary tumor. In addition, we hypothesize that Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics, and that these analyses may further refine the selection of patients most likely to benefit from Simvastatin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

6.8 years

First QC Date

December 11, 2008

Last Update Submit

January 21, 2014

Conditions

Breast Cancer

Interventions

SimvastatinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, age \>= 18 years. Page 14 of 28
  • Histologic or cytologic diagnosis of breast carcinoma.
  • Clinical T1-3 breast cancer with measurable primary breast tumor which is amenable to free-hand core biopsy
  • Patients scheduled for definitive surgery
  • Patients must not have received prior or scheduled to receive chemotherapy, hormonal therapy, radiotherapy, targeted therapy, or immunotherapy for the treatment of breast cancer.
  • Karnofsky performance status of 70 or higher.
  • Normal creatinine kinase
  • Adequate organ function including the following:
  • Bone marrow:
  • Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L
  • Hepatic:
  • Bilirubin within normal range
  • ALT or AST \<1.5 x upper limit normal
  • Renal:
  • creatinine \<= 1.5 x upper limit normal
  • +2 more criteria

You may not qualify if:

  • Current treatment with HMG-CoA reductase inhibitors or other lipid lowering drugs
  • Treatment within the last 30 days with any investigational drug.
  • Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
  • Known hypersensitivity to Simvastatin
  • Active liver disease or unexplained persistent elevations of serum transminases
  • Pregnancy.
  • Breast feeding
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (3)

  • Kumar AS, Benz CC, Shim V, Minami CA, Moore DH, Esserman LJ. Estrogen receptor-negative breast cancer is less likely to arise among lipophilic statin users. Cancer Epidemiol Biomarkers Prev. 2008 May;17(5):1028-33. doi: 10.1158/1055-9965.EPI-07-0726. Epub 2008 May 7.

    PMID: 18463402BACKGROUND

  • Campbell MJ, Esserman LJ, Zhou Y, Shoemaker M, Lobo M, Borman E, Baehner F, Kumar AS, Adduci K, Marx C, Petricoin EF, Liotta LA, Winters M, Benz S, Benz CC. Breast cancer growth prevention by statins. Cancer Res. 2006 Sep 1;66(17):8707-14. doi: 10.1158/0008-5472.CAN-05-4061.

    PMID: 16951186BACKGROUND

  • Wang T, Seah S, Loh X, Chan CW, Hartman M, Goh BC, Lee SC. Simvastatin-induced breast cancer cell death and deactivation of PI3K/Akt and MAPK/ERK signalling are reversed by metabolic products of the mevalonate pathway. Oncotarget. 2016 Jan 19;7(3):2532-44. doi: 10.18632/oncotarget.6304.

    PMID: 26565813DERIVED

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

Study Officials

  • Soo Chin Lee, MBBS, MRCP

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 15, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

SG(1)