Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
Public ClinicalTrials.gov record NCT02297698. 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
Phase II Trial of Combination Immunotherapy With Nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in High-risk HER2+ Breast Cancer Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our target study population is high-risk HER2-positive breast cancer patients. High-risk HER2-positive breast cancer patients are defined as: Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR. Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo surgery as a first intervention and are found to have ≥ 4 positive lymph nodes. Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a first intervention and are found to have 1-3 positive lymph nodes. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed.
Study identification
- NCT ID
- NCT02297698
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Oct 2014 (Type not available)
- Primary completion
- Dec 2021 (Actual)
- Completion
- Dec 2021 (Actual)
- Last update posted
- Dec 12, 2023
2014 – 2021
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| University of Miami | Deerfield Beach | Florida | 33442 | — |
| Memorial Breast Cancer Center | Hollywood | Florida | 33021 | — |
| 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 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| 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 (Good Samaritan Hospital) | Baltimore | Maryland | 21239 | — |
| The Valley Hospital | Paramus | New Jersey | 07652 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| New Mexico Cancer Care Alliance/Presbyterian Cancer Center | Albuquerque | New Mexico | 87110 | — |
| 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 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology (Cancer Care Centers of South Texas) | San Antonio | Texas | 78217 | — |
| University of Virginia Human Immune Therapy Center | Charlottesville | Virginia | 22908 | — |
| Providence Regional Medical Center | Everett | Washington | 98201 | — |
| Ascension/ 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 NCT02297698, 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 12, 2023 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02297698 live on ClinicalTrials.gov.