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Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor.

Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.

Mirvetuximab Soravtansine (IMGN853)

Kimberly Blackwell, MD

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.

Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC

Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRα)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy

Assessed by immunohistochemistry (IHC) (1) after completion of neoadjuvant chemotherapy, prior to treatment with mirvetuximab soravtansine; (2) at definitive surgery, after treatment with mirvetuximab soravtansine and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).

Assessed by immunohistochemistry (IHC) (1) at initial cancer diagnosis, prior to initiation of neoadjuvant chemotherapy; (2) after completion of neoadjuvant chemotherapy and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).

Assessed by the number of subjects that cannot receive the second dose of mirvetuximab soravtansine

Assessed by the number of subjects that have surgery delayed past 9 weeks due to TEAE

Evaluated by the number of subjects that have either a partial or complete radiologic response by 2D ultrasound. (Partial response = reduction of the largest unidimensional tumor measurement of \>30%; Complete response = no evidence of tumor remaining)

Changes in Ki67 expression will be measured before and after 2 doses of mirvetuximab soravtansine.

Changes in apoptotic markers will be measured before and after 2 doses of mirvetuximab soravtansine.

Spots Global Cancer Trial Database for mirvetuximab soravtansine (imgn853)