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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

December 30, 2008
April 12, 2012
January 2009
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00816244 on ClinicalTrials.gov Archive Site
Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Postmenopausal
Drug: Atorvastatin
Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.
Experimental: Atorvastatin
Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00816244
MAST1, EudraCT number: 2008-005863-32
No
Lund University Hospital
Lund University Hospital
Not Provided
Principal Investigator: Carsten Rose, MD University Hospital Lund
Lund University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP