Vaccination of Triple Negative Breast Cancer Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.

Clinical Trial Description

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER) negative, progesterone receptor (PR) negative and HER2-negative (= triple negative - TN) breast cancer. P10s-PADRE will be administered with MONTANIDE™ ISA 51 VG as adjuvant. Human breast cancers that express Tumor Associated Carbohydrate Antigens (TACAs) can be immunogenic, and enhancing the anti-TACA antibodies and immune effector function already present may augment the cytotoxic effects of standard therapies. A randomized two-arm, open-label, multi-center phase II trial is designed with the goal being to evaluate the efficacy of combining vaccination of the P10s-PADRE formulation with neoadjuvant chemotherapy. Patients will be randomly assigned in a 2:1 ratio to standard chemotherapy plus P10s-PADRE or to standard chemotherapy alone. Efficacy will be based on the rate of pathologic Complete Response (pCR) observed among TN breast-cancer patients treated with the combination as compared with the group of patients who receive standard chemotherapy alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02938442
Study type	Interventional
Source	University of Arkansas
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 25, 2019
Completion date	January 9, 2023

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05558917` - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery	N/A
Active, not recruiting	`NCT03664778` - Abbreviated Breast MRI After Cancer Treatment
Recruiting	`NCT03144622` - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed	`NCT05452499` - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae	N/A
Active, not recruiting	`NCT04568902` - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer	Phase 1
Completed	`NCT02860585` - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation	N/A
Completed	`NCT04059809` - Photobiomodulation for Breast Cancer Radiodermatitis	Phase 2/Phase 3
Recruiting	`NCT04557449` - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors	Phase 1/Phase 2
Completed	`NCT03698942` - Delphinus SoftVue™ ROC Reader Study
Completed	`NCT00092950` - Exercise in Women at Risk for Breast Cancer	Phase 2
Terminated	`NCT04123704` - Sitravatinib in Metastatic Breast Cancer	Phase 2
Not yet recruiting	`NCT02151071` - The Breast Surgery EnLight and LightPath Imaging System Study	Phase 1/Phase 2
Recruiting	`NCT02934360` - TR(ACE) Assay Clinical Specimen Study	N/A
Active, not recruiting	`NCT02950064` - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations	Phase 1
Completed	`NCT02931552` - Nuevo Amanecer II: Translating a Stress Management Program for Latinas	N/A
Not yet recruiting	`NCT02876848` - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)	N/A
Recruiting	`NCT02547545` - Breast Cancer Chemotherapy Risk Prediction Mathematical Model	N/A
Completed	`NCT02518477` - Preventive Intervention Against Lymphedema After Breast Cancer Surgery	N/A
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Completed	`NCT02303366` - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475	Phase 1