The Institut Català d’Oncologia (ICO) is the only Spanish centre which participates in a world-wide-scale phase II clinic trial which will test a new family of drugs for treating locally advanced breast and ovaries cancer at metastasis stage in patients carrier of the genes BRCA1 and BRCA2 mutation.

The results of pre-clinics and phase I trials have shown encouraging results as far as the anti-tumour activity of the drug and the patients’ tolerance are concerned.

The recruitment of ill women will start soon: women from all over the State who have the BRCA1 or BRCA2 genes mutated and suffer from locally advanced or metastasic breast or ovary cancer who have undergone, at least, one habitual treatment (chemotherapy or hormone-therapy).

Mutated genes:

The mutations in the genes BRCA1 and BRCA2 are closely connected to hereditary breast and ovary cancers. As an example, up to 5% of all breast tumours are a consequence of the alteration of these genes.

The BRCA1 and the BRCA2 participate in the reparation of DNA. Due to this, its malfunctioning favours the appearance of cancer. The prognosis for people who have them altered is especially bad. In the case of breasts, for example, a woman with one of the two genes mutated has a 70% probability to suffer from cancer along her life. Moreover, it is also frequent that these tumours are especially resistent to the habitual treatments with chemotherapy and hormone-therapy.

One of the options under research to treat the patients with mutated BRCA1 or BRCA2 is to change the alternative ways to repair DNA. The objective is to add an alteration to the tumorous cell which, together with the mutation that it already had, renders it impossible. In short, the goal is that the cell with inactive BRCA does not have a way to repair the defects of DNA and it eventually dies.

A new family of drugs

The first of these compounds to arrive at the phase II clinic trial is an inhibitor of the PARP way, which is one of the tools in cells to repair DNA. Pre-clinic and phase I trials, in which around 50 patients from two hospitals in the United Kingdom and Holland have participated, have shown very encouraging results as far as the anti-tumour activity of the drug is concerned. Besides, patients tolerate it well and it has few side effects.

Presently, we are starting the first phase II trial to observe the activity of the drug in patients with locally advanced breast and ovaries cancer at metastasis stage and who have a mutation in BRCA1 or BRCA2.

The trial, the first in the world with this type of drugs, will be carried out in 22 hospitals all around the world– the United States, the United Kingdom, Germany, Sweden and Australia-. In Spain, the only authorized hospital to have participants is ICO. The recruitment period starts next June and is to last one year. We will consider candidates Spanish women who have the genes BRCA1 or BRCA2 mutated and suffer from locally advanced breast or ovaries cancer at metastasis stage who have undergone, at least, one habitual treatment (chemotherapy or hormone-therapy).