TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery
Public ClinicalTrials.gov record NCT04197687. 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 to Evaluate Immune-Related Biomarkers for Pathological Response in Stage II-III HER2-Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Subsequent Randomization to Multi-Epitope HER2 Vaccine vs. Placebo in Patients With Residual Disease Post-Neoadjuvant Chemotherapy
Study identification
- NCT ID
- NCT04197687
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Academic and Community Cancer Research United
- Other
- Enrollment
- 480 participants
Conditions and interventions
Conditions
Interventions
- Multi-epitope HER2 Peptide Vaccine TPIV100 Biological
- Pertuzumab Biological
- Placebo Administration Other
- Sargramostim Biological
- Trastuzumab Biological
- Trastuzumab Emtansine Biological
Biological · Other
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
- Feb 19, 2020
- Primary completion
- Jan 14, 2025
- Completion
- Jan 14, 2025
- Last update posted
- Dec 17, 2023
2020 – 2025
United States locations
- U.S. sites
- 30
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | Recruiting |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | Recruiting |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | Withdrawn |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Withdrawn |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | Not yet recruiting |
| Middlesex Hospital | Middletown | Connecticut | 06457 | Withdrawn |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Recruiting |
| Cleveland Clinic Florida | West Palm Beach | Florida | 33401 | Withdrawn |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Not yet recruiting |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | Withdrawn |
| Carle Cancer Center NCI Community Oncology Research Program | Urbana | Illinois | 61801 | Withdrawn |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | Withdrawn |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | Recruiting |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | Not yet recruiting |
| Essentia Health NCI Community Oncology Research Program | Duluth | Minnesota | 55805 | Withdrawn |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | Withdrawn |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Withdrawn |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | 28374 | Recruiting |
| Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | Withdrawn |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | Withdrawn |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | Not yet recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Withdrawn |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | Not yet recruiting |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | Withdrawn |
| Dean Hematology and Oncology Clinic | Madison | Wisconsin | 53717 | Withdrawn |
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 NCT04197687, 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 17, 2023 · Synced May 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04197687 live on ClinicalTrials.gov.