Condition category
Cancer
Date applied
14/11/2008
Date assigned
06/03/2009
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helena Earl

ORCID ID

Contact details

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

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 below 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 measures

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

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

http://www.addenbrookes.org.uk

Funders

Funder type

Industry

Funder name

Pfizer Inc. (USA) (Educational grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes