Many women with breast cancer and lymph node involvement suffer complications resulting from the standard conventional treatment of axillary dissection. Permanent side effects include impaired sensation, chronic pain, restricted movement in the shoulder and swelling of the arm, known as lymphedema. In order to find the most effective treatment with the fewest side effects for these patients, the Swiss Group for Clinical Cancer Research (SAKK) has initiated study SAKK 23/16 (TAXIS) under the direction of the Head of Breast Surgery at the University Hospital of Basel, Professor Walter Paul Weber MD. To help it conduct this major international multicenter study, SAKK has received substantial financial support from the Rising Tide Foundation for Clinical Cancer Research (RTFCCR).
The Swiss Group for Clinical Cancer Research (SAKK) is a non-profit organization that has conducted clinical trials in oncology in hospitals in Switzerland and other countries since 1965. Each year, SAKK coordinates around 100 clinical trials to investigate the efficacy and tolerability of new cancer treatments and perfect existing ones. The Rising Tide Foundation for Clinical Cancer Research (RTFCCR) supports innovative, promising, ethically acceptable and trustworthy projects in the field of clinical cancer research. "We are delighted to have a strategic partner as important as the RTFCCR foundation on board to help us fund our academic, patient-oriented research projects. This longstanding successful collaboration is extremely important since it enables us to conduct clinical trials independently of industry. Together we are pursuing the objective of determining the best possible treatment for cancers in adults", stresses Dr. Martin Reist, SAKK CEO.
The SAKK 23/16 study is investigating the efficacy of the targeted removal of abnormal lymph nodes in the axilla followed by radiotherapy, compared to the radical removal of lymph nodes in the treatment of breast cancer with axillary lymph node involvement. The study aims to prove that the specially developed surgical technique known as tailored axillary surgery in combination with slightly more intensive irradiation is just as safe as the standard cancer treatment and leads to a better quality of life. Tailored axillary surgery is used as a personalized procedure for avoiding surgical overtreatment by removing, as selectively as possible, those lymph nodes that are affected by the cancer. Around 1,500 patients (women and men with breast cancer) in 62 centers from six countries will be needed for this trial. The generous support of the RFTCCR has enabled this important patient-oriented study to be successfully extended to other European countries, including Germany, Hungary, Austria, Italy and Lithuania, thereby ensuring that the required number of patients can be recruited.
30 female patients have already been enrolled in the study at the University Hospital of Basel under the direction of Professor Walter Paul Weber MD. "The results may change clinical practice and spare future patients from overtreatment with all its consequences. It is high time to adapt the extent of the surgery to the extent of the disease and thus remove fewer tumor-free lymph nodes than is the case with the radical standard treatment", says Professor Weber. A total of 25 hospitals in Switzerland are taking part in the study. With the follow-up period, the study will last eight years, and the first interim results should be published shortly thereafter.