At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Iza-bren (drug), Nab-paclitaxel (drug), Paclitaxel (drug), Capecitabine (drug)
- How long the study runs
- Study runs about 56 months (dates as stated)
- About the drug or intervention
- Iza-bren — drug: Specified dose on specified days · Nab-paclitaxel — drug: Specified dose on specified days · Paclitaxel — drug: Specified dose on specified days · Capecitabine — drug: Specified dose on specified days · Carboplatin — drug: Specified dose on specified days · Gemcitabine — drug: Specified dose on specified days
- Patient visit burden
- Not specified by the sponsor
In plain English
This study compares a drug called izalontamab brengitecan with chemotherapy in people with a type of breast cancer known as triple-negative breast cancer, or a similar 'ER-low, HER2-negative' type. The cancer must be locally advanced, come back after treatment, or have spread, and must not be suitable for treatment with anti-PD-1 or anti-PD-L1 immunotherapy drugs. Participants must not have had any drug treatment for this stage of their cancer before.
Who can take part
- Confirmed locally advanced, recurrent inoperable, or metastatic (spread) triple-negative breast cancer, or ER-low, HER2-negative breast cancer, based on a recent biopsy or tissue sample
- If the cancer came back, this must have been at least 6 months after finishing the last treatment given with the aim of curing it
- People with triple-negative breast cancer must not be able to have immunotherapy drugs such as pembrolizumab or atezolizumab, for example because their cancer tested negative for PD-L1, their cancer came back 6 to 12 months after earlier immunotherapy, or they have a severe autoimmune disease or other reason these drugs are unsuitable
- People with ER-low, HER2-negative breast cancer must not be suitable for hormone (endocrine) therapy
- No previous drug treatment (systemic therapy) for the advanced or spread stage of the cancer
- Cancer that can be measured on a CT or MRI scan
Who may not be able to
- People with an inherited BRCA1 or BRCA2 gene change whose doctors believe a PARP inhibitor treatment is the best first option for them
- Untreated cancer spread to the brain or spinal cord causing symptoms (people may join if this has been treated and they have recovered, with scans showing stability and stable or low steroid doses)
- Cancer spread to the membranes around the brain and spinal cord (leptomeningeal metastases)
- Serious heart problems, for example heart failure, a heart attack, uncontrolled angina or stroke in the past 6 months, certain irregular heart rhythms on an ECG, or a known heart pumping strength (LVEF) below 50%
- Previous treatment with izalontamab brengitecan or similar antibody-drug treatments targeting EGFR or HER3, or containing a topoisomerase 1 inhibitor
- Other criteria in the full trial protocol also apply — ask the trial team
What taking part involves
- • Being given either the study drug izalontamab brengitecan or chemotherapy
- • CT or MRI scans to measure the cancer
Time commitment: Not stated — ask the trial team about how long the trial lasts, how often visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2025-09-11
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase2/Phase3 - 600 participants
- • 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 take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • Truro - Local Institution - 0208
- • London - Local Institution - 0004
- • London - Local Institution - 0204
- • London - Local Institution - 0209
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day)
- ✓ immunosuppression
- ✓ iza-bren
What the study is looking for
- ✓Inclusion Criteria
- ✓Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last...
- ✓v) Prior auto-immune AE to peri-after surgery ICI that required immunosuppression. vi) Current Graves' disease with...
- ✓Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine...
- ✓No previous treatment that goes through your whole body in the that has grown locally, recurrent inoperable or that has spread setting (ie incurable setting).
See the full criteria
Where Is This Study? (7 UK sites)
Local Institution - 0208
Truro TR1 3LJ, United Kingdom
Local Institution - 0004
London EC1A 7BE, United Kingdom
Local Institution - 0204
London SE1 9RT, United Kingdom
Local Institution - 0209
London SE1 9RT, United Kingdom
Local Institution - 0171
Belfast BT9 7AB, United Kingdom
Local Institution - 0001
Manchester M20 4BX, United Kingdom
Local Institution - 0006
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT
