A Pilot Study Utilizing a HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+ Breast Cancer
The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.
• Participants must have histologically confirmed clinical stage II or III ERPR- HER2+ (per CAP criteria) invasive carcinoma of the breast
• Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status less than 2
• Patients must have normal organ and marrow function as defined below:
‣ leukocytes ≥3,000/μL
⁃ absolute neutrophil count ≥1,500/μL
⁃ platelets ≥100,000/μL
⁃ total bilirubin within normal institutional limits
⁃ AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
⁃ creatinine within normal institutional limits - OR -
⁃ creatinine clearance ≥60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Cardiac ejection fraction within institutional normal limits by either MUGA or ECHO at baseline.
• Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
• Ability to understand and the willingness to sign a written informed consent document.