22CHA436: Phase II trial to evaluate immune-related biomarkers for pathological response in stage II-III HER2-positive breast cancer receiving neoadjuvant chemotherapy with subsequent randomization to multi-epitope HER2 vaccine vs. placebo in patients wit
Principal Investigator
Study Number
STUDY02001436
Summary
This study involves people with Stage II or III HER2+ breast cancer. The purpose of this study is to learn about the effects of the investigational vaccine TPIV100, when combined with the FDA-approved drug TDM-1, on HER2+ breast cancer which remains after surgery. Researchers hope to learn if the combination will prevent HER2+ breast cancer from growing back better than TDM-1 alone. The usual treatment is chemotherapy and anti-HER2 drugs followed by surgery. All participants will have this usual treatment. Depending on the status of their cancer after surgery, some of the people in this study will receive standard chemotherapy treatment (trastuzumab and pertuzumab), while others will receive the study combination of TDM-1, an immune-activating drug called GM-CSF, and the study vaccine TPIV100 OR a placebo (an inactive drug). People who are assigned to receive TDM-1 will have a 2 out of 3 chance of receiving the study vaccine.
Phase
II
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
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