Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is node-positive (NP) (or node-negative \[NN\] if negative for both ER and PR) breast cancer patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to HLA-A24+ and HLA-A26+ as well.
Key facts
- Study ID
- NCT01570036
- Run by
- George E. Peoples
- People needed
- 275
- Starts
- 2013-05-21
- Expected to finish
- 2018-09-28
- Last updated by the study team
- 2020-12-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Samuel Oschin Comprehensive Cancer Institute - Cedars Sinai Medical Center — Beverly Hills, California, United States
- Sarcoma Oncology Research Center, LLC — Santa Monica, California, United States
- St. Joseph Heritage Healthcare — Santa Rosa, California, United States
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
- Katzen Cancer Research Center, George Washington University — Washington D.C., District of Columbia, United States
- University of Miami — Deerfield Beach, Florida, United States
- University of Miami — Kendall, Florida, United States
- University of Miami — Miami, Florida, United States
- Florida Cancer Research Institute — Plantation, Florida, United States
- University of Miami — Plantation, Florida, United States
- H. Lee Moffitt Cancer Center & Research Institute, Inc — Tampa, Florida, United States
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States
- Franciscan Health Indianapolis — Indianapolis, Indiana, United States
- Memorial Hospital of South Bend — South Bend, Indiana, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- Medstar Health - Union Memorial Hospital — Baltimore, Maryland, United States
- Medstar Health - Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
- MedStar Health - Good Samaritan Hospital — Baltimore, Maryland, United States
- The Valley Hospital — Paramus, New Jersey, United States
- Tisch Cancer Institute/Icahn School of Medicine at Mount Sinai — New York, New York, United States
- North Shore Hematology Oncology Associates — The Bronx, New York, United States
- Legacy Health, Legacy Good Samaritan Medical Center — Portland, Oregon, United States
- Thomas Jefferson University - Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
- University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- Texas Oncology (Cancer Care Centers of South Texas) — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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