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Peptide Vaccine for Breast Cancer
Study Summary
This trial is testing a cancer vaccine made of peptides that stimulate the immune system, combined with an adjuvant and GM-CSF. The primary objective is to evaluate safety, and the secondary objective is to evaluate the ability of the vaccine to create an immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I currently have an infection such as a UTI, HIV, or hepatitis.I have had my spleen removed.I have been on hormone therapy for at least 3 months.My breast cancer was surgically removed, was large or spread to lymph nodes, but not to other parts of my body.My breast cancer was surgically removed, is ER positive, and I have the HLA A0201+ gene.My cancer has spread to distant parts of my body.I haven't taken steroids or other immune-suppressing drugs for at least 6 weeks.You have a history of certain autoimmune diseases like lupus or multiple sclerosis. If you have a positive ANA test without other signs of autoimmune disease, you can still participate. A history of autoimmune hypothyroidism will not exclude you.I have not had any cancer other than non-serious skin, cervical, or superficial bladder cancer in the last 5 years.It has been less than 5 years since I finished my cancer treatment.I finished my recommended chemotherapy or surgery at least 4 weeks ago.My kidney and liver tests are within normal ranges.I do not have skin conditions that would affect injections or skin reaction assessments.I am 18 years old or older.I do not have serious illnesses like heart or liver disease that would make treatment risky.I am not currently undergoing chemotherapy, radiation, or immunotherapy.You must have a certain number of white blood cells, red blood cells, and platelets in your blood.
- Group 1: ESR1 peptide vaccine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the ESR1 peptide vaccine been given clearance by regulatory agencies?
"Considering the lack of clinical data available, our team has assigned a score of 1 to ESR1 peptide vaccine's safety profile. This reflects that this is only Phase 1 trial and limited evidence exists regarding its efficacy and safety."
Are there any vacancies available in this experiment for participants?
"Affirmative, the details on clinicaltrials.gov declare that this experiment is actively searching for research subjects. It was first posted on September 1st 2020 and last updated on September 13th 2021 with a requirement of 18 volunteers from only one medical centre."
What is the upper limit of enrolment for this experiment?
"Affirmative, clinicaltrials.gov indicates that this trial is currently recruiting participants. The first post was made on September 1st 2020 and the most recent update came on September 13th 2021. Just 18 patients are needed to enroll at one site for the study's completion."
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