ARomatase Inhibition plus/minus Src-inhibitor SaracaTinib (AZD0530) in Advanced breast CAncer Therapy (ARISTACAT): a randomised phase II study

Ailsa Oswald*, Stefan N Symeonides, Duncan Wheatley, Stephen Chan, Adrian Murray Brunt, Karen McAdam, Peter Schmid, Simon Waters, Christopher Poole, Chris Twelves, Timothy Perren, John Bartlett, Tammy Piper, Eve Macdonald Chisholm, Michelle Welsh, Robert Hill, Lisa E Hopcroft, Peter Barrett-Lee, David A Cameron

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review



The development of oestrogen resistance is a major challenge in managing hormone-sensitive metastatic breast cancer. Saracatinib (AZD0530), an oral Src kinase inhibitor, prevents oestrogen resistance in animal models and reduces osteoclast activity. We aimed to evaluate the efficacy of saracatinib addition to aromatase inhibitors (AI) in patients with hormone receptor-positive metastatic breast cancer.

This phase II multicentre double-blinded randomised trial allocated post-menopausal women to AI with either saracatinib or placebo (1:1 ratio). Patients were stratified into an “AI-sensitive/naïve” group who received anastrozole and “prior-AI” group who received exemestane. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR) and toxicity.

140 patients were randomised from 20 UK centres to saracatinib/AI (n = 69) or placebo/AI (n = 71). Saracatinib was not associated with an improved PFS (3.7 months v. 5.6 months placebo/AI) and did not reduce likelihood of bony progression. There was no benefit in OS or ORR. Effects were consistent in “AI-sensitive/naive” and “prior-AI” sub-groups. Saracatinib was well tolerated with dose reductions in 16% and the main side effects were gastrointestinal, hypophosphatemia and rash.

Saracatinib did not improve outcomes in post-menopausal women with metastatic breast cancer. There was no observed beneficial effect on bone metastases.

CRUKE/11/023, ISRCTN23804370.
Original languageEnglish
JournalBreast cancer research and treatment
Publication statusPublished - 2 Mar 2023


  • hormone receptor positive breast cancer
  • endocrine resistance
  • SRC
  • bone metastasis


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