Cancer Trials Ireland opens new breast cancer trial

Cancer Trials Ireland has today (Monday, 27th June 2016) announced that it has opened a cancer trial to test a new treatment for patients with advanced breast cancer which has not responded to currently available treatments.

The trial will test for the first time the use of the new drug copanlisib in combination with trastuzumab to treat advanced HER2-positive (HER2+) breast cancer which has progressed or recurred in patients during or following standard anti-HER2 treatment.

 It is expected that up 34 patients will take part in the trial which will be conducted over the next 2-3 years in Beaumont Hospital in Dublin, St Vincent’s University Hospital in Dublin, St. James’s Hospital in Dublin, University Hospital Galway and Cork University Hospital at a cost of approximately 750,000 euro.

The trial is being led by Professor Bryan Hennessy, Clinical Lead, Cancer Trials Ireland, and Consultant Oncologist, Beaumont Hospital. It builds on Professor Hennessy’s previous laboratory research, funded by the Health Research Board (HRB) and the Irish Cancer Society, which identified the exciting potential of the new drug copanlisib in breast cancer.

The trial is sponsored by Cancer Trials Ireland and supported by Bayer HealthCare AG.

HER2+ breast cancer is a type of breast cancer that over-produces Human Epidermal growth factor Receptor 2 (HER2), a protein that stimulates the growth of cancer cells. Current treatments that specifically target HER2, such as trastuzumab, are effective at helping to slow or even stop the growth of breast cancer cells. However, resistance to HER2-targeted treatments can develop, meaning that current treatments can become ineffective.

Professor Hennessy said that copanlisib could help to reverse the resistance of some HER2+ breast cancers to trastuzumab (a commonly used anti-HER2 treatment) and lead to a new therapy for advanced HER2+ breast cancer.

Professor Hennessy said: “It is known that HER2+ breast cancer can become resistant to current HER2 therapy. We are now learning how this happens. The switching on of a pathway called the PI3K pathway in cancer cells is often responsible. One of the possible ways this happens is through mutations (changes) that occur in a gene called PIK3CA. Research studies that we have carried out at the laboratory level have suggested that blocking the abnormal activity of the PI3K pathway in cancer cells, may help to reverse the resistance of some HER2+ breast cancers to HER2 treatments including trastuzumab ”, he said.

“Copanlisib blocks the abnormal activity in the PI3K pathway and it is currently being tested in a variety of cancers.  By combining copanlisib and trastuzumab, this trial hopes copanlisib will block the abnormal activity of the PI3K pathway and allow trastuzumab to work effectively.”

To find out more about the trial and their suitability, patients should ask their doctor or healthcare professional. Information on other cancer trials is available at

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