Breast Cancer Clinical Trial
Official title:
Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer
This Phase II will evaluate a new type of breast cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. Investigators will test new tableted preparation, V3-MOMMO, obtained from hydrolyzed, inactivated blood and tumors of patients with breast cancer. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Worldwide, breast cancer is the number one cancer in women. It affects about 12% or 1.7 mln
women worldwide. In Mongolia breast cancer is less common, occupies 5-th place by frequency
in women, the incidence is 118 per 100,000 or 1,770 cases per year.
Many different types of immunotherapy (especially checkpoint inhibitors) are being tested,
but so far the successes have been insignificant, and serious side effects are frequent and
unpredictable. This Phase II will evaluate a new type of breast cancer immunotherapy based on
a fundamentally new approach that has been successfully tested in a published clinical study
of liver cancer. Investigators will test new tableted preparation, V3-MOMMO, obtained from
hydrolyzed, inactivated blood and tumor tissues of patients with breast cancer. Study will
last 3 months, 20 patients will be recruited, given one pill per day for three months. The
primary clinical endpoint is effect on tumor size and lymph nodes burden after 3 months.
Secondary endpoint will be effect on levels of tumor markers (i.e., cancer antigen 15-3 (CA
15-3), cancer antigen 27.29 (CA 27.29), and carcinoembryonic antigen (CEA) on monthly basis
compared to baseline.
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