Status:
COMPLETED
Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Lead Sponsor:
Galena Biopharma, Inc.
Conditions:
Breast Cancer With Low to Intermediate HER2 Expression
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 va...
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 tumo...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2016
Estimated Enrollment :
758 Patients enrolled
Trial Details
Trial ID
NCT01479244
Start Date
November 1 2011
End Date
September 21 2016
Last Update
February 27 2017
Active Locations (197)
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1
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Bessemer, Alabama, United States, 35022
2
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3
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