Elacestrant + DC1 Vaccines for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a 14-day period without certain cancer treatments, like chemotherapy, hormone therapies, and targeted agents, before starting the study. If you're on these medications, you'll need to stop them for two weeks before joining the trial.
What data supports the effectiveness of the treatment Elacestrant + DC1 Vaccines for Breast Cancer?
Research shows that dendritic cell (DC) vaccines can trigger strong immune responses against breast cancer, with some studies demonstrating reduced tumor markers and tumor size in patients. This suggests that DC vaccines, a component of the treatment, may help the immune system fight breast cancer effectively.12345
What makes the Elacestrant + DC1 Vaccines treatment unique for breast cancer?
This treatment combines Elacestrant, a drug that targets estrogen receptors, with DC1 vaccines, which are designed to stimulate the immune system to attack cancer cells. This combination is unique because it uses both a targeted drug and an immune-based approach, potentially enhancing the overall effectiveness against breast cancer.12356
What is the purpose of this trial?
This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
Research Team
Aixa E Soyano Muller, MD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for individuals with hormone-positive, HER2-negative metastatic breast cancer. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular status of disease progression.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DC1 vaccines and elacestrant. DC1 vaccines are administered weekly for eight consecutive weeks, alternating between native and mutated ESR1 DC1s. Elacestrant is administered concurrently and continued after.
Induction
Pulsed DC1 vaccines are administered every four weeks for three doses after initial induction.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and overall response rate.
Treatment Details
Interventions
- DC1 native/mutated ESR1
- Elacestrant
DC1 native/mutated ESR1 is already approved in United States for the following indications:
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
The V Foundation for Cancer Research
Collaborator