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Chemotherapy

Peptide Vaccine + GM-CSF + Cyclophosphamide for Triple Negative Breast Cancer

Phase 2
Waitlist Available
Led By Kathryn J Ruddy
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HER2 IHC expression of 0 or 1+ and in-situ hybridization not done
HER2 IHC expression of 2+ and in-situ hybridization non-amplified
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion (average of 5 years)
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Triple Negative Breast Cancer
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are willing to give samples of your tissue and blood for research purposes.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (average of 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (average of 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival
Secondary outcome measures
FRalpha levels
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events 4.0
Overall survival
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (FRalpha peptide vaccine, sargramostim)Experimental Treatment4 Interventions
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo, sargramostim)Placebo Group4 Interventions
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3790
Multi-epitope Folate Receptor Alpha Peptide Vaccine
2012
Completed Phase 1
~30
Sargramostim
2008
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
51 Previous Clinical Trials
5,038 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,486 Previous Clinical Trials
41,264,597 Total Patients Enrolled
934 Trials studying Breast Cancer
1,540,727 Patients Enrolled for Breast Cancer
Kathryn J RuddyPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03012100 — Phase 2
Breast Cancer Research Study Groups: Arm I (FRalpha peptide vaccine, sargramostim), Arm II (placebo, sargramostim)
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03012100 — Phase 2
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012100 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~37 spots leftby Dec 2024