Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Public ClinicalTrials.gov record NCT01570036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01570036
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 275 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 21, 2013 (Actual)
- Primary completion
- Sep 28, 2018 (Actual)
- Completion
- Sep 28, 2018 (Actual)
- Last update posted
- Dec 2, 2020
2013 – 2018
United States locations
- U.S. sites
- 29
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Samuel Oschin Comprehensive Cancer Institute - Cedars Sinai Medical Center | Beverly Hills | California | 90211 | — |
| Sarcoma Oncology Research Center, LLC | Santa Monica | California | 90403 | — |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Katzen Cancer Research Center, George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| University of Miami | Deerfield Beach | Florida | 33442 | — |
| University of Miami | Kendall | Florida | 33176 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | — |
| University of Miami | Plantation | Florida | 33324 | — |
| H. Lee Moffitt Cancer Center & Research Institute, Inc | Tampa | Florida | 33612 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67212 | — |
| Medstar Health - Union Memorial Hospital | Baltimore | Maryland | 21218-2895 | — |
| Medstar Health - Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | — |
| MedStar Health - Good Samaritan Hospital | Baltimore | Maryland | 21239 | — |
| The Valley Hospital | Paramus | New Jersey | 07652 | — |
| Tisch Cancer Institute/Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| North Shore Hematology Oncology Associates | The Bronx | New York | 10469 | — |
| Legacy Health, Legacy Good Samaritan Medical Center | Portland | Oregon | 97210 | — |
| Thomas Jefferson University - Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology (Cancer Care Centers of South Texas) | San Antonio | Texas | 78217 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Providence Regional Medical Center | Everett | Washington | 98201 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Columbia St. Mary's | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01570036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01570036 live on ClinicalTrials.gov.