Triple-negative (hormone-independent) breast cancer, TNBC

Triple-negative (hormone-independent) breast cancer, or TNBC, affects around 10-20% of all breast cancer patients. The course of the disease is particularly unfavorable, and it has a higher mortality rate than other forms of breast cancer.

Research studies show that it is important for patients with TNBC to achieve what is known as a pathologic complete response (pCR) to treatment. This means that there are no cancer cells present in the tissue sample removed during surgery following treatment with chemotherapy and immunotherapy. The phase II trial SAKK 66/22 is investigating whether administration of the drug INT230-6 prior to breast cancer surgery can improve the pCR rate in the tumor and the affected lymph nodes. It will also analyze the tolerability of INT230-6 along with other factors such as response to treatment and the possibility of breast-conserving surgery.

What is INT230-6?

INT230-6 is a combination of the chemotherapy drugs cisplatin and vinblastine as well as a molecule that facilitates their distribution within the cancerous tissue and prevents them from entering the surrounding (healthy) tissue. In animal studies, animals treated with INT230-6 survived longer than those who did not receive this treatment. To date, there have been few clinical trials of INT230-6, yet the existing data are promising. The substance has been tested in patients with various types of cancer and has proven to be well-tolerated and effective against tumors. In a study of breast cancer patients who were waiting for direct surgery, treatment with INT230-6 resulted in a good response (considerable tumor reduction). However, INT230-6 has not yet been approved in any country.

The SAKK 66/22 trial and how it will be conducted

A total of 54 patients with early-stage TNBC can be enrolled in the trial. They will be divided into two groups at random: One group will receive injections of INT230-6 directly into the tumor followed by standard treatment, while the other group will begin immediately with standard treatment. After surgery, all patients will be followed up for 36 months and receive appropriate treatment.

The trial will be conducted at around 15 sites in Switzerland and in France. An initial analysis of the data will be carried out once all patients have undergone surgery, and the final analysis will be conducted after all patients have been followed up for at least 36 months post-surgery.