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COMPLETEDPHASE1/PHASE2

Vaccination of Triple Negative Breast Cancer Patients

A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

NCT02938442•University of Arkansas

View on ClinicalTrials.gov

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.

Detailed 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 I/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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Females of all races with biopsy-proven clinical stage I, II, or III TNBC (ER-negative, PR-negative and HER2-negative) who will undergo SoC neoadjuvant treatment
•Age 18 years and older
•ECOG Performance Status 0 or 1
•White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration
•Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration
•Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
•Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test (AST) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration
•Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration
•Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration
•Must sign an informed consent document approved by the UAMS IRB
+4 more criteria

Exclusion Criteria

•ER-positive, PR-positive, HER2-positive, inflammatory, metastatic, stage IV or recurrent breast cancer.
•Active infection requiring treatment with antibiotics.
•Existing diagnosis or history of organic brain syndrome that might preclude participation in the full protocol.
•Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.

Locations (2)

Highlands Oncology Group

Fayetteville, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Key Dates

Start Date

January 25, 2019

Primary Completion Date

January 9, 2023

Completion Date

January 9, 2023

Last Updated

November 7, 2024

Enrollment

ACTUAL participants

Conditions

Triple Negative Breast CancerBreast Neoplasms

Interventions

P10s-PADRE with MONTANIDE™ ISA 51 VG

BIOLOGICAL

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Paclitaxel

DRUG

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NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vaccination of Triple Negative Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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