Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer

April 12, 2012 updated by: Lund University Hospital

A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blood samples and three core biopsies are taken after diagnosis. Treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. Translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • University Hospital, Department of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.
  • Laboratory requirements at the day of diagnosis (t1-):Prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
  • Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • Negative pregnancy test for pre menopausal women before inclusion in the trial

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin
Drug: Atorvastatin
Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: After two weeks of treatment with statin therapy.
After two weeks of treatment with statin therapy.

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessments of apoptosis using immunohistochemistry.
Time Frame: After two weeks of treatment with statin therapy.
After two weeks of treatment with statin therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Carsten Rose, MD, University Hospital Lund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

December 31, 2008

First Posted (Estimate)

January 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAST1
  • EudraCT number: 2008-005863-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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