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

Sponsored by:	Lund University Hospital
Information provided by:	Lund University Hospital
ClinicalTrials.gov Identifier:	NCT00816244

Purpose

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	Intervention	Phase
Breast Cancer Postmenopausal	Drug: Atorvastatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Statins

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Atorvastatin Atorvastatin calcium Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atorvastatin: Experimental	Drug: Atorvastatin Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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.
Postmenopausal women. Postmenopausal status defined as ≥ 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of oophorectomy.
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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816244

Contacts

Contact: Signe Borgquist, MD, PhD	+46 46 17 85 57	signe.borgquist@med.lu.se
Contact: Carsten Rose, MD	+46 46 17 10 00	carsten.rose@skane.se

Locations

Sweden
University Hospital, Department of Oncology	Recruiting
Lund, Sweden, 221 85
Contact: Signe Borgquist, MD, PhD
Sub-Investigator: Signe Borgquist, MD, PhD

Sponsors and Collaborators

Lund University Hospital

Investigators

Principal Investigator:

Carsten Rose, MD

University Hospital Lund

More Information

No publications provided

Responsible Party:	University Hospital Lund, Department of Oncology ( Carsten Rose )
Study ID Numbers:	MAST1, EudraCT number: 2008-005863-32
Study First Received:	December 30, 2008
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00816244 History of Changes
Health Authority:	Sweden: Medical Products Agency

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

Study placed in the following topic categories:

Antimetabolites
Oxymetazoline
Skin Diseases
Phenylephrine
Antilipemic Agents
Adjuvants, Immunologic

Breast Neoplasms
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Breast Neoplasms
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases
Atorvastatin

ClinicalTrials.gov processed this record on September 02, 2009