Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
Public ClinicalTrials.gov record NCT06449222. 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
A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer
Study identification
- NCT ID
- NCT06449222
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Interventions
- BNT327 Dose Level 1 (DL1) Drug
- BNT327 Dose Level 1 (DL2) Drug
- BNT327 Equivalent Q3W Dose Drug
- BNT327 Optimized Dose Drug
- Carboplatin Drug
- Eribulin Drug
- Gemcitabine Drug
- Nab-placlitaxel Drug
- Paclitaxel Drug
Drug
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
- Aug 25, 2024
- Primary completion
- Jul 31, 2028
- Completion
- May 31, 2029
- Last update posted
- Feb 24, 2026
2024 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | — |
| Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center | Palo Alto | California | 94304-2201 | — |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica | California | 90404-2312 | — |
| Rocky Mountain Cancer Centers (RMCC) | Denver | Colorado | 80220 | — |
| Yale University - Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Carle Foundation Hospital d/b/a Carle Cancer Center | Urbana | Illinois | 61801 | — |
| HealthPartners Regions Specialty Clinics | Saint Louis Park | Minnesota | 55426 | — |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | New Brunswick | New Jersey | 08901 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| The West Clinic, P.C. d/b/a West Cancer Center | Germantown | Tennessee | 38138 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Bon Secours St. Francis Medical Center | Midlothian | Virginia | 23114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06449222, 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 Feb 24, 2026 · Synced May 6, 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 protocol, eligibility criteria, and contact information for NCT06449222 live on ClinicalTrials.gov.