Targeting the Hippo Transducer TAZ in Breast Cancer With Statins

Phase 2

• Conditions: Breast Neoplasms
• Interventions: Drug: Atorvastatin

• Registration Number: NCT02416427
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-09
• Last Update Submitted: 2015-04-09
• Study First Posted: 2015-04-15
• Last Update Posted: 2015-04-15
• Study Start: 2015-05
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Atorvastatin	Atorvastatin 80 mg/day for 3 weeks

Primary Outcome Measures

Name	Time	Method
Ki-67 reduction below the 15% (marker response).	4 weeks

Secondary Outcome Measures

Name	Time	Method
• Decreased TAZ expression	4 weeks	Reduced TAZ expression evaluated by IHC when comparing pre- and post-treatment samples. Staining intensity will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong). The final score will be obtained by considering staining intensity, percentage of expressing cells, and localization (nuclear versus cytoplasmic)
Pathway inhibition	4 weeks	Decreased expression of TAZ targets (AXL and CTGF) and Atorvastatin target (HMGCoAR) evaluated by IHC when comparing pre- and post-treatment samples. Staining intensity for all the molecular endpoints analyzed will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong).