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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
Study identification
- NCT ID
- NCT06449222
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Interventions
- BNT327 Dose Level 1 (DL1) Drug
- BNT327 Dose Level 1 (DL2) Drug
- Nab-placlitaxel Drug
- Carboplatin Drug
- Gemcitabine Drug
- Paclitaxel Drug
- Eribulin Drug
- BNT327 Optimized Dose Drug
- BNT327 Equivalent Q3W Dose 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 26, 2024 (Actual)
- Primary completion
- Aug 2028 (Estimated)
- Completion
- Jun 2029 (Estimated)
- Last update posted
- Jun 30, 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 Jun 30, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06449222 live on ClinicalTrials.gov.