Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Prof David Cameron


Contact details

Edinburgh Cancer Centre
Western General Hospital
Crewe Road South
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Version 1.0

Study information

Scientific title

Comparing ARomatase Inhibition when given with or without SaracaTinib as an Advanced breast CAncer Therapy (ARISTACAT): a randomised phase II study of aromatase inhibitionwith or without the src-inhibitor AZD0530 in post-menopausal women with advanced breast cancer



Study hypothesis

1. Comparison of progression free survival between cohort receiving aromatase inhibition plus saracatinib, versus those receiving aromatase inhibition plus placebo
2. Toxicity, response rate and overall survival.

Translational sub-studies are also planned

Ethics approval

National Research Ethics Service, West of Scotland, 6 December 2011, ref: 11/WS/0114

Study design

Multi-centre placebo-controlled double-blind randomised phase II trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Advanced Breast Cancer


The patients will be allocated to a treatment using a minimisation algorithm. Stratification factors will be:
1. AI sensitivity strata
2. Disease site (bone metastases alone versus any other sites
3. Bisphosphonate use
4. Performance status (0 v 1 v 2)
5. Treatment centre

Patients will be enrolled into one of two strata:

1. AI-sensitive/ naïve
These patients with have potentially AI-sensitive tumours
Treatment = anastrazole 1mg daily + saracatinib 175 mg daily OR exemestane 25mg daily + saracatinib 175 mg daily

2. Prior-AI
These patients will have cancers which have already progressed on an AI, but for whom there is likely to still be some endocrine sensitivity
Treatment = anastrazole 1mg daily + placebo daily OR exemestane 25mg daily + placebo daily

Saracatinib (AZD0530) is an oral src inhibitor and can be administered with or without food. The choice of either anastrazole or exemestane is driven by what would be an acceptable standard therapy for the patient, and then the patients are randomised to either get saracatinib or placebo.

Intervention type



Phase II

Drug names

Anastrazole, exemestane, saracatinib

Primary outcome measure

Current primary outcome measure as of 02/04/2019:
Progression free survival will be measured using time to progression through standard, regular, clinical assessment.

Previous primary outcome measure:
1. Progression free survival
2. Time to progression will be measured through standard, regular, clinical assessment

Secondary outcome measures

1. Toxicity
2. Change in tumour size analysed using a Waterfall plot in the two strata separately
3. Overall survival

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Females who are clearly post menopausal with Estrogen Receptor (ER) positive (Allred score ≥ 3) advanced breast cancer with at least one lesion which is measurable. They may also have additional evaluable but non-measurable lesions.
2. Patients must be performance status 0 – 2
3. Suitable for treatment with an aromatase inhibitor
4. Life expectancy > 3 months
5. Cancer must be HER2- (by FISH and/or IHC as appropriate), OR if the cancer is HER2+ the patient must not be a candidate for ant-HER2 therapy
6. All patients will need to also meet inclusion criteria for one of the two main strata:
6.1. “AI-sensitive/naive” group – either never previously treated with an aromatase inhibitor, but if treated with tamoxifen must not have rapid progression on tamoxifen (i.e. treated for at least 24 months adjuvant or ≥ 6 months in metastatic setting); or, if previously treated with an AI, only in the adjuvant or neo-adjuvant setting AND have remained free of progression for at least 12 months whilst not being treated with an AI
6.2. “Prior AI” group – patients NOT meeting the criteria in 6.1 (above), but previously treated with a non-steroidal AI without progression for at least 24 months in the (neo-) adjuvant setting or for at least 6 months for advanced disease
7. Patients who have had two lines of prior AI therapy will not be eligible UNLESS they were switched from one AI to another ONLY for reasons of toxicity, and ONLY during (neo-) adjuvant therapy AND in the absence of any evidence of progression/relapse
8. Single site of bone disease must be histologically confirmed and known not to be ER negative
9. Palliative radiotherapy can be given to bone lesions within 4 weeks of trial entry provided not more than 20% of the bone marrow is irradiated, AND there is at least one other measurable bone lesion which has clearly progressed since any prior irradiation
10. Haematology – commensurate with a phase II hormonal therapy study: Neutrophils > 1.5 * 109/l, Hb> 10.0 g/dl and Platelets > 100 * 109/l
11. Biochemistry – similar: albumin normal, ALT/AST < 2.5 ULN, Alk Phos < 5 * ULN unless of bone origin, e-GFR > 50ml/min
12. Normal urea & electrolytes
13. Patients receiving bisphosphonates are eligible, provided they are commenced before, or at, trial entry
14. Patients will be stratified by use of, or stated intention to give, bisphosphonate at randomisation
15. Patients ideally should have been on therapy for at least 1 week before starting trial therapy, but must start within 1 week after starting trial therapy

Participant type


Age group




Target number of participants

140 patients will be recruited over a 2 year period at around 20 sites in the UK

Total final enrolment


Participant exclusion criteria

1. Patients with short life expectancy or significant other co-morbidity including pulmonary fibrosis
2. Rapidly progressive visceral disease (lymphangitis, diffuse liver disease, uncontrolled CNS disease)
3. Resting ECG with a measureable QTc >480 msec
4. Any evidence of severe or uncontrolled systemic conditions (e.g. interstitial lung disease [bilateral, diffuse, parenchymal change])
5. Life expectancy < 3 months
6. Contra-indication to either AZD0530 (or excipients) or aromatase inhibition
7. Concomitant chemotherapy or anti-HER2 therapy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Edinburgh Cancer Centre
United Kingdom

Sponsor information


The Common Services Agency (UK)

Sponsor details

c/o Ms Eve Macdonald
Gyle Square
1 South Gyle Crescent
EH12 9EB
United Kingdom
+44 (0)131 275 7058

Sponsor type




Funder type


Funder name

AstraZeneca (UK)

Alternative name(s)

AstraZeneca PLC

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United Kingdom

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

Basic results (scientific)

See additional file (ISRCTN23804370_BasicResults_20Mar19.pdf)

Publication list

Publication citations

Additional files

Editorial Notes

09/07/2019: The following changes were made to the trial record: 1. A link to results was added to the results (plain English) field. 2. The total final enrolment was added. 02/04/2019: The following changes have been made: 1. The basic results of this trial have been uploaded as an additional file. 2. The primary outcome measure was updated.