Cancer is 2nd leading cause of death worldwide and despite its importance, only 25% of the drugs administered work. Breast cancer is the most common cancer in women and the second most common cancer overall. In particular, the group of advanced stage patients with corresponding metastases have a poor prognosis. Therefore, the right choice of an effective drug would be extremely important (personalized oncology).
TherapySelect has developed the Cancer Therapy Response Test (CTR Test), a laboratory-based solution for all solid cancers that tests whether drugs respond to the patient's own living tumor cells within two weeks outside the patient's body and before therapy is applied. By using the CTR test, we can triple the success of drug treatment (from 25% to 75%). The CTR test is already on the market, is used exclusively for testing chemotherapeutic agents and is currently not regularly reimbursed by health insurance companies.
This project focuses on breast cancer. There are currently 32 available drugs for breast cancer patients. Of these, 15 are chemotherapeutic agents and 17 are targeted drugs. The aim is to be able to assess these for efficacy before starting therapy, something that is currently possible in standard care and with molecular diagnostic methods for only 10 targeted drugs. The CTR test is already capable of testing the efficacy of the 15 chemotherapeutic agents. In this project, the missing group of 17 targeted drugs for the diagnostic will be added and validated. Thus, at the end of the project, all the mentioned drugs can be tested in breast cancer patients in clinical routine. To achieve this, the new drugs must be validated for CTR testing in a three-step process.
In the first step, the drugs must be established in the laboratory. This is done using a quality control system that can reproducibly measure the efficacy of the drugs in cell lines.
Then, for real tumors, the concentrations of the drugs that show the greatest distribution of efficacy between patient(s) must be determined so that one can distinguish between efficacy and inefficacy.
As a third step, the boundaries between efficacy and inefficacy must be precisely determined so that a clinically correct statement can be made. In the last two steps, living, fresh tumor samples from about 190 patients are needed. These come from the TherapySelect cryo-biobank.
In order for diagnostics for breast cancer to reach mainstream care, an intervention study will be planned during the project and funding will be sought and found.
The project will be carried out by us over 18 months. The total costs of 385.416 Euro result from:
236.250 Euro > 3 persons over 1,5 years
55,316 Euro > Laboratory rent
93.850 Euro > material costs