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PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment

Description

Brief Summary
Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.


Detailed Description
This is a multicenter, multinational, prospective, randomized, double-blind, controlled Phase 3 study. The subjects eligible for this trial have an early stage node-positive breast cancer. Their tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered after completion of front-line, standard of care therapy (surgery, radiation therapy, and chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment. NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The active portion of the study will last three years (36 months). The follow-up will last from 5 to 10 years. Endpoints: 1. Primary efficacy endpoint: - 3-year DFS 2. Secondary efficacy endpoints: - 5- and 10-year DFS - 3-year OS - 5- and 10-year OS - Safety profile, and adverse events (AEs) - Patterns of recurrence to include Time to recurrence (TTR), time to local recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases (TTBM) Safety Assessments: Subjects will be assessed at every study visit for the safety endpoints, AEs,vital signs, physical examinations and laboratory data; yearly follow-up of survival will include imaging studies, ECGs, MUGA or ECHO scans and concomitant medications.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • - Pathological diagnosis of invasive adenocarcinoma of the breast - Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery - One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II:
  • Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
  • BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes - Node-positive disease - Primary tumor stage T1-3 at initial diagnosis - HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH) - HLA-A2 or HLA-A3 haplotype - Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both - Completed radiation therapy - No evidence of disease - Able and willing (or have legal representative) to understand the study and provide consent Key

  • Bilateral breast malignancy or suspicious mass in opposite breast
  • Inflammatory breast malignancy
  • History of prior breast cancer, ductal carcinoma in situ
  • Prior trastuzumab therapy
  • New York Heart Association Stage 3 or 4 cardiac disease
  • Sensory/motor neuropathy ≥ Grade 2
  • Autoimmune diseases or immune deficiency disease
  • Subjects on chronic steroid therapy, other immunosuppressive therapy

Sites

  • California

    • University of Southern California/Norris Cancer Hospital, Los Angeles, California, 90033
    • Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, 90048
    • St. Jude Medical Center, Virginia K. Crosson Cancer Center, Fullerton, California, 92801
    • South Orange County Surgical Medical Group, Laguna Hills, California, 92653
    • Moores UC San Diego Cancer Center (UCSD), San Diego, California, 92093
    • University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center, San Francisco, California, 94115

  • Oregon

    • OHSU Knight Cancer Institute, Portland, Oregon, 97239

  • Colorado

    • University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, Colorado, 80045

  • Washington

    • Multicare Health System-Research Institute, Tacoma, Washington, 98405
    • Swedish Cancer Institute Research, Seattle, Washington, 98104

  • Texas

    • Clinical Trials of Texas, Inc, San Antonio, Texas, 78229
    • Brooke Army Medical Center (now SAMMC), Ft. Sam Houston, Texas, 78234
    • UT Southwestern Medical Center / Simmons Comprehensive Cancer Center, Dallas, Texas, 75390
    • Baylor College of Medicine, Houston, Texas, 77030
    • University of Texas MD Anderson Cancer Center, Houston, Texas, 77030

  • Kansas

    • Cancer Center of Kansas, Wichita, Kansas, 67214

  • North Dakota

    • St. Alexius Medical Center, Mid Dakota Clinic, PC, Bismarck, North Dakota, 58501

  • Wisconsin

    • Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center, Milwaukee, Wisconsin, 52336

  • Louisiana

    • Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, 70809

  • Tennessee

    • The West Clinic, Memphis, Tennessee, 38120

  • Illinois

    • Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center, Chicago, Illinois, 60611
    • Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center, Chicago, Illinois, 60611

  • Alabama

    • Alabama Oncology, Bessemer, Alabama, 35022

  • Kentucky

    • James Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, 40202

  • Lille

    • Centre Oscar Lambret, Cédex, Lille, 59020

  • Ukraine

    • Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy, Lviv, 79031
    • Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council, Zaporizhia, 69040
    • Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council, Zaporizhia, 69040
    • Chernivtsi Regional Clinical Oncology Center, Day Care Unit, Chernivtsi, 58013
    • State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine, Kharkiv, 61024
    • State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine, Kharkiv, 61024
    • Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy, Dnipropetrovsk, 49102

  • Germany

    • Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie, Heidelberg, 69120
    • Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik, Stuttgart, 70374
    • Universität Marburg, Marburg, 35043

  • Ramat Gan

    • Sheba Medical Centre, Tel Hasomer, Ramat Gan, 52621

  • Kyivskyi District

    • Kharkiv Regional Clinical Oncology Center, Day Care Unit, Kharkiv, Kyivskyi District, 61070
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