Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer

Inclusion Criteria

• •1. Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
• •2. Patients diagnosed with triple negative breast cancer, (stages II-III, or high risk T1c disease) found to have gpNMB expression at or above 25%), and who are appropriate candidates for neo-adjuvant therapy. Patients must be willing to undergo lumpectomy (with radiation therapy) or mastectomy following neo-adjuvant therapy.
• •3. Subjects may be female or male.
• •4. ECOG Performance Status of 0-2.
• •5. Age ≥ 18 years.
• •6. Subject must have a life expectancy ≥ 6 months.
• •7. Absolute neutrophil count ≥ 1,500 cells/mm3
• •8. Platelets ≥ 100,000 cells/mm3
• •9. Hemoglobin ≥ 9g/dl (Note: The use of transfusion to achieve Hemoglobin ≥ 9 g/dl is acceptable)
• •10. Serum creatinine OR GFR ≤ 1.5 x institutional upper limit normal (IULN)
• •11. Bilirubin ≤ 1.5 x IULN OR Direct Bilirubin ≤ULN for patients with total bilirubin levels \>1.5×ULN
• •12. ALT and AST ≤ 2.5 IULN
• •13. Alkaline phosphatase ≤ 2.5 IULN
• •14. Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for at least 1 year following last dose of study drug.
• •a. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL\]
• •i. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and for at least 1 year following participation and the potential risk factors for an unintentional pregnancy
• •ii. The following birth control methods are allowed during the study: Barrier methods (Intra-uterine device (IUD), Diaphragm with spermicide, Cervical cap with spermicide, Condom with spermicide) or Abstinence (no heterosexual activity)
• •b. Non-vasectomized males must agree to use adequate contraception for at least 120 days after the last dose of study drug
• •i.The following birth control methods are allowed during the study: Partner is not WOCBP or is taking hormonal contraceptives, Barrier methods (Intra-uterine device (IUD), Diaphragm with spermicide, Cervical cap with spermicide, Condom with spermicide) or Abstinence (no heterosexual activity)
• •ii. Males must also abstain from sperm donations for at least 120 days after the last dose of study drug