A Phase I Study of Cancer Peptides plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer
Vaccinating against ER resistant neoepitopes using multiple peptide vaccines immunologically enhanced by co-administration with GM-CSF
Phase I trial of cancer vaccine supporting this approach against ER
Demonstration of a HER2 vaccine alone in HER2+ metastatic cancer patients
In a past-clinical trial, we found that a vaccine against HER2 could elicit striking HER2-specific immunity in mice and that its use as a solo agent in patients (in a Phase I trial) was safe and could elicit HER2-specific memory T-cell responses that associated with enhanced progression free survival. This successful trial motivated our search for agents that would improve T-cell functionality against the Estrogen Receptor as a means to combat ER+ cancers.
Clinical Studies supporting the use of ESR1 peptide vaccines
Clinical Studies using peptide vaccines in breast cancer
Clinical studies have demonstrated that peptide vaccines can be safely administered to breast cancer patients that are capable of eliciting immune responses against their intended targets. While this trial did not target the critically important Estrogen Receptor protein, it demonstrated the safety and potential of a multi-peptide vaccine in advanced breast cancer patients, over 40% having ER+ breast cancer.
Rationale, Entry Criteria and Design
All patients enrolled in this trial will receive the ESR1 peptide + GM-CSF vaccine. The schedule for vaccination and immune monitoring is detailed in the chart above. Patients will remain on their standard-of-care therapies throughout the trial with additional tests and immune analyses performed as indicated.
Possible Side Effects
Who is eligible?
Because this is the first time this vaccine is being given patients, there may be risks, discomforts, drug interactions or side effects that are not yet known.
Based on previous Phase I trials if peptide vaccines, there are several possible side effects. These possible side effects and risks are details in the link below.
-This Phase I clinical study is restricted to patients with histologically confirmed, resected ER+ breast cancer without evidence of distant metastases
-Patients must be HLA-A02+, which can be determined by a simple blood test to identify if a potential patient is trial eligible
-Patients must have completed any chemotherapy or HER2-based therapies at lest four weeks prior to initial vaccination
-Ongoing treatment with endocrine therapies are permitted
-Detailed eligibility criteria are viewable at the link below