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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449222
The ClinicalTrials.gov registry entry for NCT06449222 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (66% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
-
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
Explore more on PlainTrial
Triple Negative Breast Cancer
All registered trials for this condition
Locally Advanced Breast Cancer
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.