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Cancer Vaccine for Triple Negative Breast Cancer
Study Summary
This trial is testing a vaccine for triple negative breast cancer. The vaccine is designed to wake up the immune system to help it recognize and destroy cancer cells.
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.Side effects data
From 2021 Phase 4 trial • 87 Patients • NCT04326920Trial Design
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Who is running the clinical trial?
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- My kidney function is normal, based on recent tests.I have recovered from major infections or surgeries and don't have other serious illnesses that would prevent me from following the treatment plan.My breast cancer is triple negative and in stage IB, II, or III.I have an autoimmune disease that isn't managed well with treatment.I agree not to take systemic steroids until 1 month after my 2nd booster vaccine.My hemoglobin level is at least 10 mg/dl after recent treatments.Your AST/SGOT levels are not more than 1.5 times the upper limit of normal. This was checked within 60 days before enrolling in the study and at least 28 days after receiving standard treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I do not use NSAIDs daily for more than a week, except for low-dose aspirin.I finished my standard cancer treatment, including immunotherapy and radiotherapy, between 28 and 365 days ago.I agree to use birth control during the study and for 1 month after, unless I cannot get pregnant due to surgery or menopause.I will inform my doctor immediately if I become or suspect I am pregnant during the study.My bilirubin levels are within normal range.I am fully active or can carry out light work.My platelet count is at least 100,000 and was tested within the last 60 days.I have a history of HIV, hepatitis B, or hepatitis C.I am a man willing to use contraception during the study.You are allergic to sargramostim or other yeast-based products.My lymphocyte count is at least 800 and was measured after my last treatment.Your white blood cell count is at least 3000 per cubic millimeter within the specified time frame.I have mild side effects from previous breast cancer treatment.I am 18 years old or older.I agree not to have major surgery until my treatment ends, except for port removal.
- Group 1: Prevention (STEMVAC vaccine, sargramostim)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
How many research participants will be included in this experiment?
"Yes, this clinical trial is currently recruiting patients. As of right now, 33 individuals are needed at 2 different locations. The study was first posted on December 1st, 2022 and has since been updated once on November 1st, 2022."
Are there any current openings for patients who wish to participate in this clinical trial?
"The trial is currently looking for patients, as seen on clinicaltrials.gov. The original posting was on December 1st, 2022 and the most recent update was on November 1st, 2022."
What does this research hope to uncover about the treatment?
"The purpose of this study is to assess the efficacy of a new immunotherapy treatment over a period of 10 months. The primary outcome measure will be the cellular immune response magnitude, and secondary outcomes include activation status and repertoire diversity of peripheral blood T-cells, as well as the kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts. Safety and incidence of adverse events will also be monitored throughout the study."
Has Sargramostim been federally recognized as a safe and effective treatment?
"While there is some evidence to support its safety, Sargramostim did not receive a higher score because Phase 2 trials lack data demonstrating efficacy."
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