Cancer Research UK’s Drug Development Office (DDO) has joined forces with academia and industry to trial an experimental drug from AstraZeneca called AZD4547 in combination with existing therapies, to treat post-menopausal women whose breast cancer has spread and is no longer responding to standard treatment.

The Phase IIa clinical trial will be run through the Cancer Research UK and NIHR Experimental Cancer Medicine Centre (ECMC) in conjunction with the Imperial Clinical Trials Unit Section on cancer (ICTU-Ca), Imperial College London. It will recruit post-menopausal women with oestrogen positive breast cancer who are no longer responding to either anastrozole or letrozole – standard treatments for this patient group.

The trial will be divided into two groups. In one group, patients will receive AstraZeneca’s experimental treatment AZD4547 alongside either anastrozole or letrozole.

In the second group, patients will be treated with exemestane alone.

The trial will evaluate whether the combination of this experimental drug with an existing therapy that has begun to fail may halt the progression of the disease, and make the tumour respond again to the original therapy.

AstraZeneca is the first pharmaceutical industry partner to join the ECMC Combinations Alliance, which launched in 2011. The alliance aims to increase patient access to trials of potential new cancer treatments by combining molecularly-targeted experimental drugs developed and owned by the company – with standard chemotherapy, radiotherapy and other new drugs.

This study is the third launched by the Alliance, and AstraZeneca is providing both supply of AZD4547 and additional funding, with Cancer Research UK’s DDO also providing support. Imperial College London is sponsoring the trial.

Chief investigator, Professor Michael Seckl, at Imperial College London, said: “The opening of this trial is great news. It’s an incredibly tough part of my job telling breast cancer patients that they are no longer responding to the drugs they are taking. We hope that this trial will be a step forward in finding new and better ways to treat advanced breast cancer, to increase survival from this disease.

“More women are surviving breast cancer than ever before. But while we’re making great progress in developing new targeted treatments there’s still an urgent need for medicine that will treat the disease once it has spread.”

Andrew Foxley, clinical programme director for AZD4547 at AstraZeneca, said: “AstraZeneca has a long-standing commitment to cancer research and has developed medicines that are making a meaningful difference for people with breast cancer. We believe that collaboration is crucial to finding solutions in the fight against cancer and are pleased to partner with others in the UK who share our dedication to bringing new medicines to patients.”

Dr Ian Walker, head of alliance management at Cancer Research UK’s DDO, said: “This is the third trial we’ve launched through collaboration with AstraZeneca – with others in the pipeline. This unique alliance is powering UK research to bring together combinations of new and existing drugs in early clinical trials to find better ways to treat patients and increase survival from a range of cancers.

“Without this important alliance these trials might not be possible. We want to build on the foundations established with AstraZeneca to add additional partners to collaborate with us in the future. Our aim is to set up cross-company agreements to provide access to a larger number of potential treatment combinations.”

Source: CRUK