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

• ClinicalTrials.gov Identifier: NCT00816244
• Recruitment Status: Completed
• First Posted: January 1, 2009
• Last Update Posted: April 13, 2012
• Sponsor: Lund University Hospital
• Information provided by (Responsible Party): Lund University Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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. ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Sweden

University Hospital, Department of Oncology

Lund, Sweden, 221 85

Sponsors and Collaborators

Lund University Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Feldt M, Bjarnadottir O, Kimbung S, Jirström 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.

• Responsible Party: Lund University Hospital
• ClinicalTrials.gov Identifier: NCT00816244
• Other Study ID Numbers: MAST1; EudraCT number: 2008-005863-32
• First Posted: January 1, 2009
• Last Update Posted: April 13, 2012
• Last Verified: March 2012

Keywords provided by Lund University Hospital:

Breast cancer; Postmenopausal; Neo-adjuvant; Tumor proliferation; Statin; Atorvastatin; Ki67; Translational research; Cell cycle regulators; Gene expression; Genomic profiling; Apoptosis; Window-of-opportunity

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Atorvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors