A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Based Treatment with Focus on Mechanisms of Resistance to Endocrine Based Treatment (fulvestrant/aromatase inhibitors alone or in combination with a cdk4/6 inhibitor) in Patients With Advanced Breast Cancer

Phase 1

• Conditions: Estrogen receptor positive metastatic or locally advanced inoperable breast cancer.; MedDRA version: 20.0Level: LLTClassification code 10006192Term: Breast cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000494-20-SE
• Lead Sponsor: Skåne University Hospital, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-20
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

1.Patients diagnosed with ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic
endocrine based treatment. If IHC analysis is not available from the metastatic tissue, the ER and HER2 status is determined from archived
primary tumor.
2.Age > 18 years.
3.Performance status of Eastern Cooperative Oncology Group (ECOG) = 2.
4.Metastatic disease must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination,
computerized tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Bone
metastases alone are allowed.
5.Pre-menopausal patients must consent to undergo either surgical or chemical castration during the duration of the treatment and utilize an
effective contraception barrier method.
6.Patient not willing to undergo study specific biopsy from the metastatic site should preferably have enough metastatic tumor sample
material archived to perform DNA extraction from formalin fixed paraffin embedded (FFPE) material.
7.Patient must be capable and willing to grant signed informed consent prior to any procedure related with this study as well as to allow
access to FFPE biopsies for DNA extraction and for serial CTCs ctDNA analysis. Biopsy of the metastatic site upon progression is not
mandatory but desirable.
8.Signed informed consent according to ICH/GCP, and national/local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1.Previous treatment for metastatic breast cancer (previous systemic treatment for early breast cancer allowed).
2.Brain as the only site of metastatic breast cancer.
3.Ongoing treatment with statins (e.g. simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, or rosuvastatin), anion-exchangers (e.g.
colestyramin or colesevelam), fibrates (e.g. gemfibrozil), nicotin-acids (or acipimox) or inhibitors of intestinal cholesterol uptake (e.g.
ezitimibe) for the first part of the trial.
4.Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal
dysfunction (creatine kinase level) more than three times the upper limit of the normal range.
5.The patient is unable to pause treatment with anticoagulants/antiagregants prior to biopsy during the recommended times.
6.History of haemorrhagic stroke.
7.Pregnancy or breast-feeding.
8.Untreated psychiatric disorders that will impair the patient’s ability to comply with study treatment or protocol.
9.History of allergic reactions attributed to compounds of similar chemical or biological composition to either of the study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified