NCT02958852

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.

Detailed description

A randomized, open-labelled, phase II trial in the first and second-line metastatic treatment setting, comparing standard endocrine treatment (aromatase inhibitor (AI)) with endocrine treatment plus atorvastatin (1:1). Upon progression in the first line setting, and as part of the translational studies on mechanisms of resistance to endocrine therapy, the patients will receive second line endocrine treatment using fulvestrant. Upon progression to first line treatment, patients that were receiving atorvastatin will stop this treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Daily orally
DRUG	Letrozole and atorvastatin	Daily orally
DRUG	Fulvestrant	Fulvestrant will be used as second line treatment upon progression on first line treatment with letrozole +/- atorvastatin.

Timeline

• Start date: 2025-01-02
• Primary completion: 2025-01-02
• Completion: 2025-01-15
• First posted: 2016-11-08
• Last updated: 2025-09-10

Locations

1 site across 1 country: Sweden