Breast Cancer Triple Negative Clinical Trial
Official title:
Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRĪ±)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy
The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.
The folate receptor alpha protein is important in tumor growth and can be over-expressed in
some tumor cells. The word "over-expressed" in this situation means that there are too many
copies of the protein on the surface of the cell when compared to a healthy, normal cell, and
this helps the tumor continue to grow in size. Mirvetuximab soravtansine acts by targeting
the folate receptor in tumor cells. In animal models, mirvetuximab soravtansine is highly
effective in decreasing tumor size. This suggests that mirvetuximab soravtansine may help
shrink or stop growth of folate receptor alpha positive breast cancer in this study.
In this study the investigator will be looking at how folate receptor alpha expression
changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will
also look to evaluate the safety of this regimen, measure any change in tumor size, associate
folate receptor alpha expression with a change in tumor size, and describe any changes in
Ki-67 and percent of apoptotic cells in this population.
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