P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+2 More
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel - Biological
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer vaccine in people with TNBC. The vaccine will be given with standard neoadjuvant chemotherapy (chemo given before surgery). The trial will compare how well the vaccine works when added to standard neoadjuvant chemo to standard neoadjuvant chemo given alone.

Eligible Conditions
  • Breast Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: At the time of definitive surgery (4-8 weeks after chemo); between Week 20 and Week 23

Week 23
Safety/tolerability
Week 70
Demonstration of clinical response

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Chemo+Vaccine Arm
1 of 2
Active Control
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel · No Placebo Group · Phase 1 & 2

Chemo+Vaccine Arm
Biological
Experimental Group · 1 Intervention: P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel · Intervention Types: Biological
Control Arm
Drug
ActiveComparator Group · 1 Intervention: Doxorubicin + Cyclophosphamide + Paclitaxel · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the time of definitive surgery (4-8 weeks after chemo); between week 20 and week 23

Who is running the clinical trial?

University of ArkansasLead Sponsor
459 Previous Clinical Trials
146,486 Total Patients Enrolled
18 Trials studying Breast Cancer
2,265 Patients Enrolled for Breast Cancer
Issam Makhoul, MDPrincipal InvestigatorUniversity of Arkansas
7 Previous Clinical Trials
228 Total Patients Enrolled
3 Trials studying Breast Cancer
116 Patients Enrolled for Breast Cancer
Sindhu Malapati, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Breast Cancer
61 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient has a good performance status.
The person must have a platelet count of 100,000 or more within three weeks of registration.
A bilirubin level that is ≤ 2 times the institutional upper limit of normal (IUL) of normal obtained within 3 weeks prior to registration is considered acceptable.
A person's SGPT or ALT level cannot be more than two times the normal level in order to be registered for the study.
People with a serum creatinine level of 1.8 mg/dl or less within the three weeks prior to registration are eligible to participate in this study.
The test for serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST) will be ≤ 2 times the upper limit of normal (ULN) obtained within 3 weeks prior to registration.
are eligible Females who have TNBC (ER-negative, PR-negative and HER2-negative), and who are going to have SoC neoadjuvant treatment are eligable.
People who are at least 18 years old are allowed to vote.
This means that the person's white blood cell count was 3,000 or more per millimeter cubed within three weeks of registration.
You must sign an informed consent document approved by the UAMS IRB.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.