On October 4, 2018, the Training - Session for Researchers Involved in International, Multicentric, Randomized Trials - Tanvex TX05-03 and TX05-03E EU, which was attended by Associate Professor Irakli Kokhreidze, Vice-Rector of Tbilisi State Medical University was held in Budapest (Hungary). The trials are aiming at conducting chemo-immunotherapy in patients with breast cancer of II-III stages and to evaluate TX05 equivalency to Herceptin. The assessment of equivalence between the study preparation and Herceptin will be conducted according to the results obtained after the therapy at neoadjuvant regime, namely, pCR – pathologic complete response.
The main criteria to be involved in the trial are:
1. Patient’s informed consent;
3. Age> 18 years
4. Hystomorphologically proved diagnosis of invasive breast cancer, II-IIIa of stages, operable and immunomorphologically confirmed HER2 - with hyper-expression.
5. Planned Strategy – performance of mastectomy or organ maintenance treatment (with axillary lymphadenectomy, or sentinel lymph node biopsy) after neoadjuvant therapy.
According to Professor Irakli Kokhreidze - "The planned large-scale, multicenter III phase trials will enable citizens of our country to undergo treatment and relevant examinations (including high-tech) for free, within the research budgets, including the complications (if the complication was caused by preparation) patients should be compensated by the insurance company ". The trials will be conducted at Tbilisi State Medical University's first university clinic. The principal researcher (PI - Principal Investigator) - Associate Professor Irakli Kokhreidze.