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

Inclusion Criteria

• •Signed informed screening consent form with HIPAA authorization for release of personal health information.
• •Research personnel will review medical records of subjects consenting to screening to ensure no obvious factors would exclude them from the treatment portion of the study (e.g., history of cirrhosis of the liver) and to confirm diagnosis and staging
• •Histological confirmation of triple negative breast cancer (TNBC) biopsy report
• •Stage 1-3 tumors \> 1cm in maximal diameter.
• •Standard neoadjuvant chemotherapy NAC and definitive surgery planned (NOTE: NAC chemotherapy will be per standard of care, and not dictated by this clinical trial)
• •Must be able to supple sufficient tissue (block or slides) from diagnostic biopsy to undergo testing.
• •Written informed consent and HIPAA authorization for release of personal health information.
• •Must have operable tumor ≥ 1cm determined by and obtained less than 9 weeks after completion of standard NAC
• •Must be able to meet study schedule: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC.
• •Willing to undergo biopsy for research purposes only (before and after), and to allow surgical tissue sample from surgery to be used for research purposes
• •May have symptoms however must be ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work)
• •Demonstrate adequate organ function through labs
• •Females of childbearing years must have a negative serum pregnancy test within 48 hours prior to dose 1 mirvetuximab soravtansine. NOTE: Sexually mature females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
• •Females of childbearing potential must be willing to abstain from heterosexual activity or to use two effective methods of contraception from the time of informed consent until 4 months after the last dose of mirvetuximab soravtansine