Aromasin® randomised trial +/- Sutent® as neoadjuvant therapy for post-menopausal women with breast cancer

ISRCTN	ISRCTN11277575
DOI	https://doi.org/10.1186/ISRCTN11277575
Protocol serial number	ARTiST version 1.0
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Pfizer (Educational grant)

Submission date: 14/11/2008
Registration date: 06/03/2009
Last edited: 13/10/2017

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helena Earl
Scientific

Oncology Department
Box 193
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Phase II randomised open-label multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	ARTiST: Aromasin® Randomised TrIal +/- Sutent® as neoadjuvant Therapy for post-menopausal women with breast cancer
Study acronym	ARTiST
Study objectives	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(s)	Cambridgeshire 1 Research Ethics Committee, 30/12/2008, ref: 08/H0304/125
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Exemestane (Aromasin®), sunitinib (Sutent®)
Primary outcome measure(s)	Ki67 response to therapy. Assessed by biopsy analysis pre-, during (week 3) and post-treatment (week 18)
Key secondary outcome measure(s)	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
Completion date	28/02/2011
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	96
Key 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)
Key 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
Date of first enrolment	01/03/2008
Date of final enrolment	28/02/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oncology Department

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/10/2017: Trial stopped early in June 2010 because of ‘futility’ outcome analysis of sunitinib in metastatic breast cancer.