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 with residual disease post-neoadjuvant chemotherapy
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04197687?term=NCT04197687&draw=2&rank=1#eligibility
Summary
Primary Goal
2.11 To evaluate invasive disease free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ BC with residual disease post-neoadjuvant chemotherapy.
2.12 To evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.
2.2 Secondary Goals
2.21 To evaluate immunogenicity of multi-epitope HER2 vaccine in combination with T-DM1 maintenance therapy.
2.22 To evaluate the immune-related tissue and blood biomarkers for complete pathological response in patients with stage II-III HER2+ BC receiving neoadjuvant chemotherapy.
2.3 Correlative Research
2.31 To determine host immune factors which are critical to prevent disease recurrence in HER2+ BC patients.
2.311 To determine if the development of T cell immunity, as assessed by IFN-Ɣ ELIspot, to HER2 correlates with improved iDFS.
2.312 To determine the distribution of the helper T cell response among helper T cell differentiation states.
2.313 To determine if augmenting CD4 helper T cell immunity augments HER2-specific antibody immunity induced by trastuzumab.
2.314 To determine if HLA genotypes are associated with antibody responses before and after neoadjuvant therapy and vaccination.
2.315 To determine gene expression levels in tumors from patients who did not achieve pCR that are associated with recurrence.
2.32 To determine tumor intrinsic genotyping and phenotyping features associated with therapeutic failure to HER2 immune-based approaches.
2.321 To determine whether HER2 monoclonal antibody therapy induces HER2 loss and modulation of HER2-specific adaptive immune responses.
2.322 To determine loss-of-function mutations in breast tumor that associate with lack of pCR and lack of immune response to HER2+ neoadjuvant treatment.