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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816244
• Other study ID #: MAST1
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2008
• Last updated: April 12, 2012
• Start date: January 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Postmenopausal

Intervention

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

Locations

Country	Name	City	State
Sweden	University Hospital, Department of Oncology	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Assessments of apoptosis using immunohistochemistry.		After two weeks of treatment with statin therapy.	No