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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00816244
First received: December 30, 2008
Last updated: April 12, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin 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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00816244     History of Changes
Other Study ID Numbers: MAST1, EudraCT number: 2008-005863-32
Study First Received: December 30, 2008
Last Updated: April 12, 2012
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014