IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

New drug Izalontamab Brengitecan tested against standard chemotherapy for advanced breast cancer.

NCT: NCT06926868 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2025-09-11 · Est. Completion: 2030-05-15

Plain English Summary

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) is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Breast Neoplasms. This trial tests a new drug called Izalontamab Brengitecan against standard chemotherapy options. It is for patients with advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer who cannot receive immunotherapy. Participants will be randomly assigned to receive either the new drug or the treatment chosen by their doctor. Standard chemotherapy options include paclitaxel, nab-paclitaxel, carboplatin with gemcitabine, or capecitabine. The trial aims to enroll 500 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with previously untreated, locally advanced, recurrent, inoperable, or metastatic TNBC or ER-low, HER2-negative breast cancer. Patients must not be eligible for anti-PD-1/PD-L1 treatments or endocrine therapies. Must have measurable disease. Patients with recurrent disease must have relapsed at least 6 months after curative intent therapy. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how long patients live without their cancer getting worse, which is crucial for understanding how effective the new drug is in controlling the disease. The specific primary outcome measures are: Progression-Free Survival (PFS) (Approximately 31 months from first participant randomization). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatments in advanced breast cancer subtypes that are not responding to or eligible for current immunotherapy or endocrine therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Neoplasms, where improved treatment options are needed.

Investor Insight

This trial represents a significant investment in a novel antibody-drug conjugate for a challenging breast cancer subtype, with potential to capture a share of the advanced breast cancer market if suc Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific type of breast cancer and if you meet all the eligibility requirements. Participation involves receiving either the new drug or standard chemotherapy, with regular monitoring for side effects and disease progression. You will be randomly assigned to one of the treatment groups, and your doctor will discuss the specific treatment schedule and potential side effects with you. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria

* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:

  i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.
* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
* Measurable disease by CT or MRI as per RECIST v1.1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06926868?

NCT06926868 is a Phase 3 INTERVENTIONAL 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)." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 500 participants.

What conditions does NCT06926868 study?

This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.

What treatments are being tested in NCT06926868?

The interventions being studied include: Iza-bren (DRUG), Nab-paclitaxel (DRUG), Paclitaxel (DRUG), Capecitabine (DRUG), Carboplatin (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT06926868?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06926868?

This trial is currently "Recruiting." It started on 2025-09-11. The estimated completion date is 2030-05-15.

Who is sponsoring NCT06926868?

NCT06926868 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06926868?

The trial aims to enroll 500 participants. The trial is currently recruiting and accepting new participants.

How is NCT06926868 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06926868?

The primary outcome measures are: Progression-Free Survival (PFS) (Approximately 31 months from first participant randomization). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06926868 being conducted?

This trial is being conducted at 20 sites, including Hot Springs, Arkansas; Cerritos, California; Long Beach, California; Los Angeles, California and 16 more sites (United States).

Where can I find official information about NCT06926868?

The official record for NCT06926868 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06926868. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06926868 testing in simple terms?

This trial tests a new drug called Izalontamab Brengitecan against standard chemotherapy options. It is for patients with advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer who cannot receive immunotherapy.

Why is this trial significant?

This trial addresses a critical need for new treatments in advanced breast cancer subtypes that are not responding to or eligible for current immunotherapy or endocrine therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06926868?

Common side effects may include fatigue, nausea, diarrhea, and low blood cell counts. Specific risks related to Izalontamab Brengitecan include potential allergic reactions and effects on the liver. Your doctor will closely monitor you for any side effects and manage them as needed. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06926868?

Ask your doctor if this trial is a good fit for your specific type of breast cancer and if you meet all the eligibility requirements. Participation involves receiving either the new drug or standard chemotherapy, with regular monitoring for side effects and disease progression. You will be randomly assigned to one of the treatment groups, and your doctor will discuss the specific treatment schedule and potential side effects with you. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06926868 signal from an investment perspective?

This trial represents a significant investment in a novel antibody-drug conjugate for a challenging breast cancer subtype, with potential to capture a share of the advanced breast cancer market if suc This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either the new drug or the treatment chosen by their doctor. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.