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A new drug combination to treat women with metastatic HER2-positive breast cancer that is based on prior preclinical studies from Dublin City University will enter clinical development in a Phase 1 clinical trial named  CAROLINE-1, which will commence later this month.

Researchers at DCU's National Institute for Cellular Biotechnology (NICB) have previously demonstrated the benefit of combining neratinib, an irreversible pan-HER kinase inhibitor, with standard HER2 antibody therapies, trastuzumab and pertuzumab, in laboratory models. This work has been carried out in collaboration with Puma Biotechnology, Inc., a U.S.-based biopharmaceutical company.

Ireland will become the first country to assess the new combination in women with metastatic HER2-positive breast cancer. The aim of the investigation is to improve on the response currently achieved with standard treatments.

HER2-positive breast cancer accounts for approximately 560 of the 2,500 new breast cancer cases diagnosed in Ireland each year.  About 15% of these patients will develop metastatic disease. While the treatment options for patients where this disease has spread are successful for some, for many patients the disease returns. The Caroline-1 study is the first step in the development of a new combination for those patients. The focus of the Phase 1 clinical trial is to confirm the treatment is safe and tolerable and, once this is shown, a Phase 2 clinical trial will look closely at the ability of the new combination to successfully control this cancer.

Explaining the background to the breakthrough, Dr. Denis Collins said,

“This development has been a truly translational process and is the culmination of many years' work by researchers based in the NICB, most notably Dr. Norma O’Donovan and funders Cancer Clinical Research Trust, The Caroline Foundation and BreastPredict. We found that adding neratinib to existing HER2 antibody therapies improved the anti-cancer effect in the laboratory setting and this provided a compelling rationale for examination in the clinic.”

The CAROLINE-1 study is sponsored by Puma Biotechnology, Inc. and led by Professor John Crown of St. Vincent’s University Hospital, who was recently re-appointed as the Thomas Baldwin Chair of Translational Medicine at DCU.

Commenting on the upcoming clinical trial, Professor Crown said,

“This Phase 1 clinical trial will be conducted in women who have metastatic HER2-positive breast cancer.  Whilst women with this disease usually respond well initially to treatment, their response is typically not permanent and the disease will likely return.  We hope that this drug combination will prolong the time until a women’s disease returns.

“This is an exciting accomplishment, as the trial is based on the work we conducted in our lab at DCU,” added Professor Crown. “We have worked with Puma Biotechnology, Clinical Oncology Development Europe and Saint Vincent’s University Hospital to bring the first-in-world CAROLINE-1 study to Ireland.

CAROLINE-1 is named for Caroline Dwyer-Hickey who tragically passed away as a result of metastatic breast cancer. The Caroline Foundation was set up in her honour and supports the laboratory work at DCU, which has led to this trial. Our hope is that this trial will improve the treatment options available to women with metastatic HER2-positive breast cancer.”



2nd July, 2019
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