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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816244
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):
Lund University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Postmenopausal Drug: Atorvastatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
Study Start Date : January 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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. [ Time Frame: After two weeks of treatment with statin therapy. ]

Secondary Outcome Measures :
  1. Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816244

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University Hospital, Department of Oncology
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University Hospital
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Principal Investigator: Carsten Rose, MD University Hospital Lund
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lund University Hospital Identifier: NCT00816244    
Other Study ID Numbers: MAST1
EudraCT number: 2008-005863-32
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: March 2012
Keywords provided by Lund University Hospital:
Breast cancer
Tumor proliferation
Translational research
Cell cycle regulators
Gene expression
Genomic profiling
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors