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

NCT ID: NCT00816244

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-03-31

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.

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.

Conditions

Breast Cancer; Postmenopausal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

Interventions

Atorvastatin

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carsten Rose, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Lund

Locations

University Hospital, Department of Oncology

Lund, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33292612 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25925673 (View on PubMed)

Other Identifiers

EudraCT number: 2008-005863-32

Identifier Type: -

Identifier Source: secondary_id

MAST1

Identifier Type: -

Identifier Source: org_study_id