Your session is about to expire
← Back to Search
Cancer Vaccine
Peptide Vaccine for Breast Cancer
Phase 1
Recruiting
Research Sponsored by Herbert Lyerly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ongoing endocrine therapies are permitted as long as they have been administered for at least 3 months prior to study enrollment
Patients with histologically confirmed, resected, breast cancer with pT3 or greater T stage with any N stage and M0 pTxN+M0 (i.e., N1,2 or 3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with a specific type of breast cancer that's been surgically removed but hasn't spread far. They should have finished any standard treatments like chemo at least 4 weeks ago and can't be more than 5 years out from those treatments. Their cancer must be estrogen receptor positive, they need to have certain immune system markers (HLA A0201+), and their organs must function well.Check my eligibility
What is being tested?
The study tests a new vaccine made from cancer peptides targeting the estrogen receptor, combined with GM-CSF and Montanide ISA adjuvant to boost immune response. It aims to check safety first, then how well it triggers an immune reaction in patients who've resisted hormone therapy.See study design
What are the potential side effects?
Potential side effects aren't detailed here, but as this is an early-phase trial focusing on safety, common reactions may include redness or pain at the injection site, flu-like symptoms such as fever or fatigue, and possibly allergic reactions to vaccine components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on hormone therapy for at least 3 months.
Select...
My breast cancer was surgically removed, was large or spread to lymph nodes, but not to other parts of my body.
Select...
My breast cancer was surgically removed, is ER positive, and I have the HLA A0201+ gene.
Select...
It has been less than 5 years since I finished my cancer treatment.
Select...
I finished my recommended chemotherapy or surgery at least 4 weeks ago.
Select...
My kidney and liver tests are within normal ranges.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Secondary outcome measures
detection of ESR mutant-specific memory T cells against at least one of the 5 immunizing peptides by Cytof analysis
Trial Design
1Treatment groups
Experimental Treatment
Group I: ESR1 peptide vaccineExperimental Treatment1 Intervention
200 mcg ESR1 peptides plus 1ml Montanide and 100 mcg GM-CSF administered subcutaneously weeks 0, 1, 2, 4, 5, 6 for a total of 6 injections.
Find a Location
Who is running the clinical trial?
Herbert LyerlyLead Sponsor
4 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Breast Cancer
9 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: ESR1 peptide vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger