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New drug that targets metastasing breast cancer in clinical phase III trial

Protein kinases are a major focus of modern cancer research. Since it has become known that these enzymes play a role in the development of tumours, researchers around the world are concentrating on finding drugs to inhibit overactive protein kinases and prevent cancer cells from growing. One of these active substances is currently being tested at the Tumour Biology Centre in Freiburg as part of a worldwide phase III clinical trial.

Dr. Klaus Mross, head of Clinical Trials at the Tumour Biology Centre in Freiburg (Photo: B. Riess/Tumour Biology Centre)
“The drug targets precisely defined structures of complex signalling pathways involved in cell division as well as inhibiting the growth of tumour tissue,” explains Dr. Klaus Mross, head of Clinical Trials at the Tumour Biology Centre in Freiburg. The trial is recruiting women with metastasing mammacarcinoma who have undergone anthracyclin and taxoid therapies.

Standard treatment of metastasing mammacarcinoma usually involves intravenous chemotherapy. The most effective drugs are anthracyclins and taxoids. These two substance classes delay the progression of the disease in some patients, leading to a considerable reduction in tumour growth. However, the therapy is often not successful for long as women quickly become resistant to the drugs.

The drug, sunitinib, is no classical cytostatic drug. It is a multikinase inhibitor and able to suppress many important signalling pathways involved in tumour growth. The drug inhibits the formation of new vessels (angiogenesis inhibition), amongst other things.

”Patients with metastasing mammacarcinoma who have been treated with sunitinib in the phase II study generally tolerated the drug well. Unexpected severe side effects have not occurred,” said Mross. “The data on the efficiency of the drug were excellent and a phase III worldwide clinical trial has been started in order to amass further information on the effectiveness of the therapy.” Treatment will be offered to women who have already undergone anthracyclin and taxoid therapies but who have had no more than two combination therapies during the metastasing stage of their disease. The trial participants receive either sunitinib or capecitabin tablets/capsules. If the tumour no longer responds to treatment with capecitabin, the women will be given sunitinib in order to ensure that all study participants have the opportunity to be treated with the new multikinase inhibitor.

Keyword: protein kinase inhibitors

More than 500 protein kinases are known. These enzymes transmit cellular signals and affect numerous biological processes. A number of kinases are believed to play a role in cancer, inflammatory processes or cardiovascular diseases. The protein kinases form a complex network that is disturbed in people suffering from such diseases. Nowadays, there are drugs available that have a therapeutic effect on tumour growth by targeting and inhibiting individual protein kinases. The breakthrough with this new generation of drugs was achieved with a drug that was approved in 2001 for the treatment of chronic myeloid leukaemia and in 2002 for the treatment of gastrointestinal stromal tumours. Sunitinib is approved for the treatment of metastasing renal cell carcinoma and advanced gastrointestinal stromal tumours. However, the potential application spectrum of the drug in cancer treatment is considerably larger.

Source: University of Freiburg press release - 1 December 2008
Further information:
Dr. Klaus Mross
Head of Clinical Trials
Tumour Biology Centre
Breisacher Str. 117
79106 Freiburg
Tel.: +49 (0)761 206 1220
Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/new-drug-that-targets-metastasing-breast-cancer-in-clinical-phase-iii-trial