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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.
Duke University Medical Center
Durham, North Carolina, United States
Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine
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).
Time frame: Baseline up to 9 weeks
Change in breast tumor FRα expression before and after neoadjuvant chemotherapy
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).
Time frame: Baseline up to 9 weeks
Total number of grade 3 and 4 toxicities
Graded via NCI CTCAE v4.03
Time frame: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) precluding second dose
Assessed by the number of subjects that cannot receive the second dose of mirvetuximab soravtansine
Time frame: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) delaying surgery
Assessed by the number of subjects that have surgery delayed past 9 weeks due to TEAE
Time frame: Baseline up to 9 weeks
Total number of partial or complete responses
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)
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Time frame: Baseline up to 9 weeks
Change in tumor cell proliferation, as measured by Ki67 expression
Changes in Ki67 expression will be measured before and after 2 doses of mirvetuximab soravtansine.
Time frame: Baseline up to 9 weeks
Change in tumor cell death markers
Changes in apoptotic markers will be measured before and after 2 doses of mirvetuximab soravtansine.
Time frame: Baseline up to 9 weeks