Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06449222 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
A Phase 2 study of Triple Negative Breast Cancer and Locally Advanced Breast Cancer, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT06449222: Active Phase 2 study of Triple Negative Breast Cancer and Locally Advanced Breast Cancer, sponsored by BioNTech SE.
NCT06449222 is a Phase 2 study of Triple Negative Breast Cancer and Locally Advanced Breast Cancer that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 83 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06449222, a Phase 2 study of Triple Negative Breast Cancer and Locally Advanced Breast Cancer, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
In the combination treatment regimen according to the (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE version 5.0). By treatment arm and overall.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG BNT327 Dose Level 1 (DL1)
- DRUG BNT327 Dose Level 1 (DL2)
- DRUG Nab-placlitaxel
Study Locations (20)
Other
- Peninsula Oncology Centre - Frankston
- Peter MacCallum Cancer Centre - Melbourne
- Baskent Universitesi Tip Fakultesi Adana Hastanesi - Adana
- Medical Park Seyhan Hospital - Adana
- Sakarya University - Faculty of Medicine - Adapazarı
- Hacettepe Universitesi Kanser Enstitusu - Ankara
- Sbu Dr.A.Y. Ankara Onkoloji SUAM - Ankara
California
- Beverly Hills Cancer Center - Beverly Hills
- Valkyrie Clinical Trials - Los Angeles
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center - Palo Alto
- Saint John's Health Center - John Wayne Cancer Institute (JWCI) - Santa Monica
Tennessee
- The West Clinic, P.C. d/b/a West Cancer Center - Germantown
- SCRI Oncology Partners - Nashville
Colorado
- Rocky Mountain Cancer Centers (RMCC) - Denver
Connecticut
- Yale University - Yale Cancer Center - New Haven
Illinois
- Carle Foundation Hospital d/b/a Carle Cancer Center - Urbana
Minnesota
- HealthPartners Regions Specialty Clinics - Saint Louis Park
New Jersey
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What the registry record for NCT06449222 still lists
NCT06449222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06449222 names 20 study sites across 10 states, led by Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06449222 about?
NCT06449222 is a clinical study titled "Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy". 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 tr...
What is the current status of trial NCT06449222?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2024-08-26. Estimated completion is 2029-06.
What conditions does trial NCT06449222 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Metastatic Triple Negative Breast Cancers.
What interventions are being tested in trial NCT06449222?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), BNT327 Dose Level 1 (DL1) (DRUG), BNT327 Dose Level 1 (DL2) (DRUG), Nab-placlitaxel (DRUG).
Who is sponsoring clinical trial NCT06449222?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06449222 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06449222's enrollment target sits among peer trials
83 58th of 118 higher than 61 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients
RECRUITING · Phase 2
-
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
RECRUITING · Phase 2
-
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
RECRUITING · Phase 2
-
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02974647 · 83 participants · Phase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- NCT03919292 · 83 participants · Phase 1
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- NCT04626674 · 83 participants · Phase 1
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- NCT05277168 · 83 participants · Phase 1
A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI