Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

The limited liability company Panagen has designed the preparation named Panagen in a form of tablets, which is represented by a fragmented nucleoprotein complex isolated from the human placenta. The method allows for extraction of a full-fledged genomic DNA with retention of its fragments that are tightly associated with the nuclear matrix proteins. The length of fragmented DNA varies from 200 to 6000 base pairs. This trial is a double-blind multisite placebo-controlled sequentially randomized phase II trial involving two groups of patients. Totally, 80 stage II breast cancer cases with an increased risk or stage III-IV breast cancer cases (with distant metastases) requiring chemotherapy will participate in this trial. All patients will be sequentially randomized, that is, any patient independently of the time she is included into this study may fall into one of the two groups. The patients will be divided into two groups at a ratio of 3 : 1; the first group receiving the preparation Panagen will contain 60 persons and the second one, receiving placebo, 20 persons. For the reasons of ethics, the size of the second group minimally possible for obtaining statistically significant data is chosen. The patients will be subject to a standard chemotherapy, including 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil; all preparations are administered intravenously once a day. In this trial, the patients will receive three chemotherapy courses with an interval of 3 weeks between the courses (unless an interruption is required). On the background of this chemotherapy, the patients will receive the preparation Panagen at a dose of 30 mg/day or a placebo with a fractional uniform administration during the active day period, which will amount to one tablet six times a day (every 2 h). The patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (day 3) and continue its administration for 17 days to and thorough day 20 after the chemotherapy. If the next chemotherapy course is delayed, the patients continue taking Panagen. The intake should be stopped 1 day before the next chemotherapy course. It is admissible to delay the next chemotherapy course by 1 week.