Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ARTiST version 1.0
Study information
Scientific title
ARTiST: Aromasin® Randomised TrIal +/- Sutent® as neoadjuvant Therapy for post-menopausal women with breast cancer
Acronym
ARTiST
Study hypothesis
Angiogenesis is important for the growth of all cancers and there is emerging evidence that angiogenesis inhibitors will be an important therapeutic option in breast cancers. The multi-targeted signal transduction inhibitor sunitinib has shown efficacy in advanced disease. Exemestane is a steroidal aromatase inhibitor commonly used.
Hypothesis: Simultaneous blockage of two important pathways will lead to a superior clinical response.
Ethics approval
Cambridgeshire 1 Research Ethics Committee, 30/12/2008, ref: 08/H0304/125
Study design
Phase II randomised open-label multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Breast cancer
Intervention
The participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Arm A: Exemestane (Aromasin®) (oral) 25 mg/day for 18 weeks
Arm B: Exemestane (Aromasin®) (oral) 25 mg/day for 18 weeks + sunitinib (Sutent®) (oral) 37.5 mg/day for weeks 1 to 16, followed by a 2-week break before surgery
Intervention type
Drug
Phase
Phase II
Drug names
Exemestane (Aromasin®), sunitinib (Sutent®)
Primary outcome measure
Ki67 response to therapy. Assessed by biopsy analysis pre-, during (week 3) and post-treatment (week 18)
Secondary outcome measures
1. Clinical response rate (cRR), assessed by clinical examination at weeks 3, 9 and 17
2. Radiological response rate (rRR), assessed by US scan at weeks 3, 9 and 17
3. Clinical/radiological response among patients over-expressing EGFR/HER-2, assessed by US scan/clinical examination at weeks 3, 9 and 17
4. Complete pathological response (pCR), assessed from the tumour tissue removed at surgery
5. Circulatory endothelial cells (CEC) and circulatory endothelial progenitor (CEP) levels, assessed by blood sample pre-, during (week 3) and post-treatment (week 18)
6. Analysis of candidate genes and global gene expression profiling to identify molecular markers of response or resistance. Assessed by biopsy analysis pre-, during (week 3) and post-treatment (week 18)
7. Disease free and overall survival. After surgery, patients will have a hospital visit every 6 months for 5 years
Overall trial start date
01/03/2008
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Females aged 50 to 80 years old
2. Ultrasound size: greater than 1 cm
3. Diagnosis of invasive breast cancer on core biopsy
4. Patients with localised, locally advanced invasive breast cancer
5. Histological grade: G1-3
6. Oestrogen Receptor (ER) positive (Allred score >=4)
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
96
Participant exclusion criteria
1. Previous history of cancer excluding basal cell carcinoma or cervical carcinoma in-situ
2. Previous deep vein thrombosis or pulmonary embolism
3. Uncontrolled hypertension
4. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
5. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
6. Ongoing cardiac dysrhythmias of >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) grading version 3.0), atrial fibrillation of any grade, or prolongation of the QTc interval >470 msec
7. Treatment with terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, ketoconazole or indapamide
8. Known HIV positive, or acquired immunodeficiency syndrome (AIDS) related illness
Recruitment start date
01/03/2008
Recruitment end date
28/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oncology Department
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
R&D Department
Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Pfizer (Educational grant)
Alternative name(s)
Pfizer Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
No trial results – trial stopped after only one patient recruited
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list