NCT00816244

Brief Summary

The purpose of this study is to monitor:

  • Tumor biological alterations following two weeks of neo-adjuvant statin therapy.
  • Effects of statins on tumor proliferation.
  • Functional studies on the mevalonate pathway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2009

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

December 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 13, 2012

Status Verified

March 1, 2012

Enrollment Period

3.2 years

First QC Date

December 30, 2008

Last Update Submit

April 12, 2012

Conditions

Breast CancerPostmenopausal

Keywords

Breast cancerPostmenopausalNeo-adjuvantTumor proliferationStatinAtorvastatinKi67Translational researchCell cycle regulatorsGene expressionGenomic profilingApoptosisWindow-of-opportunity

Outcome Measures

Primary Outcomes (1)

  • Tumor biological alterations following two weeks of neo-adjuvant statin therapy in postmenopausal breast cancer patients; to evaluate the tumor proliferation using Ki67 as proliferation marker.

    After two weeks of treatment with statin therapy.

Secondary Outcomes (1)

  • Assessments of apoptosis using immunohistochemistry.

    After two weeks of treatment with statin therapy.

Study Arms (1)

Atorvastatin

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.

Atorvastatin

Eligibility Criteria

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

You may qualify if:

  • Women with primary breast cancer who are candidates for radical surgery.
  • Breast tumours clinically ≥ 15 mm, Nx, M0.
  • Breast tumours identified on mammography and verified on fine needle aspiration.
  • Age \> 18 years.
  • Performance status of ECOG ≤ 1.
  • Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

You may not qualify if:

  • Ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
  • Prior breast cancer treatment.
  • Current HRT.
  • Known liver disease.
  • History of hemorrhagic stroke.
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Department of Oncology

Lund, 221 85, Sweden

Location

Related Publications (2)

  • Feldt M, Menard J, Rosendahl AH, Lettiero B, Bendahl PO, Belting M, Borgquist S. The effect of statin treatment on intratumoral cholesterol levels and LDL receptor expression: a window-of-opportunity breast cancer trial. Cancer Metab. 2020 Nov 23;8(1):25. doi: 10.1186/s40170-020-00231-8.

    PMID: 33292612DERIVED

  • Feldt M, Bjarnadottir O, Kimbung S, Jirstrom K, Bendahl PO, Veerla S, Grabau D, Hedenfalk I, Borgquist S. Statin-induced anti-proliferative effects via cyclin D1 and p27 in a window-of-opportunity breast cancer trial. J Transl Med. 2015 Apr 29;13:133. doi: 10.1186/s12967-015-0486-0.

    PMID: 25925673DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Carsten Rose, MD

    University Hospital Lund

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2008

First Posted

January 1, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-03

Locations

SE(1)