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NCT06926868 · ClinicalTrials.gov registry record · Phase 2
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
A Phase 2 study of Breast Neoplasms, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06926868: Recruiting Phase 2 study of Breast Neoplasms, sponsored by Bristol-Myers Squibb.
NCT06926868 is a Phase 2 study of Breast Neoplasms that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 500 participants, below the 564-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06926868, a Phase 2 study of Breast Neoplasms, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Primary Outcome
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG Iza-bren
Study Locations (20)
California
- Helios Clinical Research - Cerritos
- Local Institution - 0307 - Cerritos
- Local Institution - 0308 - Cerritos
- Local Institution - 0309 - Cerritos
- Local Institution - 0311 - Long Beach
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- Local Institution - 0358 - Stanford
Illinois
- Local Institution - 0278 - Chicago
- Local Institution - 0280 - Chicago
- Decatur Memorial Hospital - Decatur
Colorado
- Local Institution - 0289 - Aurora
- Rocky Mountain Cancer Centers - Denver
Florida
- Local Institution - 0282 - Miami
- Local Institution - 0296 - Pembroke Pines
Georgia
- Local Institution - 0294 - Atlanta
- Northside Hospital - Atlanta
Arkansas
- Local Institution - 0303 - Hot Springs
Delaware
- Medical Oncology Hematology Consultants, PA - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-09-11 |
| Est. Completion | 2030-05-15 |
| Phase | Phase 2 |
What NCT06926868 shows while recruiting
NCT06926868 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 564-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06926868 names 20 study sites across 7 states, led by California, Illinois, Colorado.
Frequently Asked Questions
What is clinical trial NCT06926868 about?
NCT06926868 is a clinical study titled "A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)". The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for...
What is the current status of trial NCT06926868?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2025-09-11. Estimated completion is 2030-05-15.
What conditions does trial NCT06926868 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT06926868?
The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Iza-bren (DRUG).
Who is sponsoring clinical trial NCT06926868?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06926868 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
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 NCT06926868's enrollment target sits among peer trials
500 21st of 97 higher than 76 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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
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