Aromasin® randomised trial +/- Sutent® as neoadjuvant therapy for post-menopausal women with breast cancer
| ISRCTN | ISRCTN11277575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11277575 |
| Secondary identifying numbers | ARTiST version 1.0 |
- 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
Scientific
Oncology Department
Box 193
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Phase II randomised open-label multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2008 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Oncology Department
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department
Box 277
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.addenbrookes.org.uk |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Industry
Pfizer (Educational grant)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | No trial results – trial stopped after only one patient recruited |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/10/2017: Trial stopped early in June 2010 because of ‘futility’ outcome analysis of sunitinib in metastatic breast cancer.
