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Cancer Vaccine for Breast Cancer (Cornerstone001 Trial)
Cornerstone001 Trial Summary
This trial is to study a new cancer vaccine to see if it is effective and safe in patients with HER2-low expression and hormone receptor-negative breast cancer.
Cornerstone001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCornerstone001 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Cornerstone001 Trial Design
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Who is running the clinical trial?
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- My cancer was stage I, II, or III before surgery.I am currently on immune suppression therapy or was on it within the last 4 weeks.I do not have active infections like TB, hepatitis B, C, or HIV.My cancer is HER2 low according to specific guidelines.My cancer is not driven by estrogen or progesterone hormones.I haven't had cancer, except for non-dangerous skin cancer or localized cancer, in the last 5 years.My organs are functioning well.I still have cancer in my breast after initial treatment.You have had a disease that makes your immune system attack your own body, or a condition that causes inflammation.You have had a bad reaction to rhGM-CSF in the past.I am fully active or can carry out light work.
- Group 1: AST-301(pNGVL3-hICD)+Chemotherapy
- Group 2: Placebo + Chemotherapy
- 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
Does this study still have room for new participants?
"Yes, the information on clinicaltrials.gov says that this study is presently searching for candidates. The clinical trial was originally posted on 2/28/2022 and was last edited on 5/2/2022. The trial is looking for 146 patients across 1 locations."
How many individuals are being observed in this clinical trial
"Yes, as indicated on clinicaltrials.gov, this trial is looking for enrollees at the present moment. The first posting was on February 28th, 2022 and the most recent update was on May 2nd, 2022. So far, 1 site has enrolled 146 patients."
Has Pembrolizumab received regulatory approval from the FDA?
"Pembrolizumab falls into the Phase 2 category, meaning that while there is evidence of its safety, currently there is no data to support efficacy."
What other drugs has Pembrolizumab been tested with in previous clinical trials?
"Pembrolizumab is being studied in 1364 active clinical trials, with 251 of them being Phase 3 studies. While some of these investigations are taking place in Houston, Texas, there are 48889 total research sites for Pembrolizumab across the globe."
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