PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVaxâ„¢Treatment
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVaxâ„¢Treatment
Purpose of this trial:
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. NeuVaxâ„¢ 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.
NeuVaxâ„¢ 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:
Primary efficacy endpoint:
Secondary efficacy endpoints:
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.
Key Inclusion 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:
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 Exclusion Criteria:
Fresno, California 93720, United States
Fullerton, California 92801, United States
Los Angeles, California 90033, United States
Los Angeles, California 90048, United States
San Francisco, California 94115, United States
Fort Lauderdale, Florida 33308, United States
Chicago, Illinois 60611, United States
Brownstown, Michigan 48183, United States
Pittsburgh, Pennsylvania 15232, United States
Dallas, Texas 75390, United States
Milwaukee, Wisconsin 52336, United States
Hradec Králové, 500 05, Czechia
Cédex, Lille 59020, France
Saint Herblain, Nantes Cedex, Loire-Atlantique 44805, France
Essen, D-45136, Germany
Frankfurt, 60590, Germany
Heidelberg, 69120, Germany
Münster, 48149, Germany
Würzburg, D-97080, Germany
Miskolc, 3526, Hungary
Tel Hasomer, Ramat Gan 52621, Israel
Kamienskiego, Wroclaw 51-124, Poland
Lodz, 93-513, Poland
Baia Mare, Maramures, 430031, Romania
Sochi, Krasnodarskiy Kray 354057, Russia
Krasnodar, 350040, Russia
Kryvyi Rih, Dnipropetrovsk Oblast 50000, Ukraine
Mariupol, Donetsk Oblast 87500, Ukraine
Dnipropetrovsk, 49102, Ukraine
Kharkiv, 61024, Ukraine
Kiev, 04107, Ukraine
Lviv, 79031, Ukraine
Zaporizhia, 69040, Ukraine
Leeds, West Yorkshire LS9 7TF, United Kingdom
Nottingham, NG7 2UH, United Kingdom