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Peptide Vaccine + GM-CSF + Cyclophosphamide for Triple Negative Breast Cancer
This trial is testing a vaccine made from a person's white blood cells mixed with tumor proteins, given with sargramostim (GM-CSF) and cyclophosphamide, to see if it can prevent the recurrence of stage 1-3 triple negative breast cancer.
- Triple Negative Breast Cancer
- Breast Cancer
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You can still take common medications like aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), statins, and other non-cancer, non-autoimmune treatments.You have not taken a PD-1 or PD-L1 checkpoint inhibitor (like pembrolizumab) within the last 3 months.You have evidence of breast cancer spreading to other parts of your body. However, if you have a new breast tumor that appeared on the same side or opposite side of a previous breast cancer, it's allowed as long as the previous breast cancer was more than 5 years ago.If the results from different biopsy and surgical samples disagree about the hormone receptor (ER, PR) or HER2 status, you can still participate in the study as long as one of the samples meets the required criteria and you are not planning to use hormone therapy in the future.It's okay if you have fungal or viral infections on your skin, nails, mouth, or genital area that haven't spread to other parts of your body.It seems like the criterion you provided is incomplete. Could you please provide the complete criterion so that I can summarize it for you?You are willing to give samples of your tissue and blood for research purposes.You have taken or are currently taking trastuzumab or other medications that target the Her2 protein.You cannot participate if you are pregnant or planning to become pregnant because we are not sure if the experimental treatment is safe for the baby.You have had an allergic reaction to GM-CSF before.
- Group 1: Arm I (FRalpha peptide vaccine, sargramostim)
- Group 2: Arm II (placebo, sargramostim)
- 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
What adverse effects have been reported with administering the Multi-epitope Folate Receptor Alpha Peptide Vaccine?
"Our experts at Power rated the safety of Multi-epitope Folate Receptor Alpha Peptide Vaccine a 2, as data collected from Phase 2 trials demonstrate its relative security yet there is no evidence for efficacy."
Are there any records of other experiments involving Multi-epitope Folate Receptor Alpha Peptide Vaccine?
"In 1997, Multi-epitope Folate Receptor Alpha Peptide Vaccine was first researched by City of Hope Comprehensive Cancer Center. Since then, 1850 studies have been completed. Presently 865 clinical trials are actively recruiting participants across the USA, with a notable concentration in Boston MAe Vaccine was first researched by City of Hope Comprehensive Cancer Center. Since then, 1850 studies have been completed. Presently 865 clinical trials are actively recruiting participants across the USA, with a notable concentration in Boston MA."
In how many distinct areas is this clinical experiment being managed?
"This medical study has 11 unique sites of operation, including the Massachusetts General Hospital Cancer Center in Boston, Ochsner Medical Center Jefferson in New Orleans, and Mayo Clinic Arizonal Cancer Center in Boston, Ochsner Medical Center Jefferson in New Orleans, and Mayo Clinic Arizona in Scottsdale. Additional locations are available as well."
What is the typical purpose for administering Multi-epitope Folate Receptor Alpha Peptide Vaccine?
"The Multi-epitope Folate Receptor Alpha Peptide Vaccine is typically used to treat the proliferation of lung cancer. In some cases, it has been employed as an intervention for lymphoma, Hodgkin's disease, bone marrow transplantation and multiple sclerosisf lung cancer. In some cases, it has been employed as an intervention for lymphoma, Hodgkin's disease, bone marrow transplantation and multiple sclerosis."
How many participants have joined this research endeavor?
"Unfortunately, this research is currently not accepting applicants. This experiment was first posted in March of 2017 and last updated on September 23rd 2022. Fortunately, there are 4,600 studies investigating breast cancer and 865 experiments exploring the Multi-epitope Folate Receptor Alpha Peptide Vaccine that are actively recruiting patients at present."
Are recruitment efforts still ongoing for this clinical experiment?
"At the present moment, this clinical trial is not actively recruiting. Initially posted on March 31st 2017 and last updated on September 23rd 2022, people seeking to participate in medical research should consider one of the 4600 trials enrolling patients with breast cancer or 865 studies for Multi-epitope Folate Receptor Alpha Peptide Vaccine which are currently open."
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