RecruitingPHASE2, PHASE3INTERVENTIONAL

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)

This research study, called IZABRIGHT-Breast01, is looking into a new treatment called iza-bren for women and men with certain types of advanced breast cancer. Specifically, it's for triple-negative breast cancer (TNBC) that has spread, or a type of breast cancer called ER-low, HER2-negative, if standard hormone treatments aren't suitable. Participants in the study will either receive iza-bren or a common chemotherapy drug. This study is for people who haven't had previous treatment for their advanced cancer and who aren't able to use certain immunotherapy drugs. The main aim is to see how well iza-bren works and if it's safe compared to current treatments.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

500

Start

11 Sep 2025

Estimated completion

15 May 2030

Breast Neoplasms

What is this study about?

This study is investigating a new medication called iza-bren for advanced breast cancer. It's for two specific types of breast cancer: triple-negative breast cancer (TNBC) and a group called ER-low, HER2-negative breast cancer. 'Advanced' means the cancer has spread locally or to other parts of the body and can't be removed by surgery. This study is aimed at people who haven't had previous treatment for their advanced cancer.

The new drug, iza-bren, is a 'bi-specific antibody-drug conjugate'. This means it's designed to attach to two specific proteins on cancer cells (EGFR and HER3) and deliver a cancer-fighting medicine directly to them, hopefully causing fewer side effects to healthy cells. The study is comparing iza-bren to standard chemotherapy drugs that doctors might use in this situation.

It's important to note that this study is specifically for patients who are not suitable for certain common immunotherapy treatments (called anti-PD(L)1 drugs) or, for ER-low, HER2-negative patients, if usual hormone therapies aren't an option. By participating, you could help researchers understand if iza-bren is a better and safer option for this group of patients.

Key takeaways

Tests a new drug (iza-bren) for specific advanced breast cancers.
Compares iza-bren with standard chemotherapy.
For advanced triple-negative or ER-low, HER2-negative breast cancer.
Only for patients who can't receive certain immunotherapy drugs.
Participation involves regular hospital visits for treatment and monitoring.
Aims to find out if iza-bren is safe and effective.

Who may be eligible?

To be considered for this study, you must have a confirmed diagnosis of either advanced triple-negative breast cancer (meaning your cancer cells don't have oestrogen receptors, progesterone receptors, or high levels of HER2 protein) or ER-low, HER2-negative breast cancer (where oestrogen or progesterone receptors are present at low levels but HER2 is negative). This diagnosis needs to be recent and confirmed by a lab test.

You should not have received any previous treatment for your advanced cancer. If your cancer has come back after treatment with the aim to cure it, at least six months should have passed since your last treatment. Also, a key condition is that you are not suitable for certain standard immunotherapy drugs (like anti-PD-1 or anti-PD-L1 therapies), perhaps because your cancer doesn't have the right markers for it, or you have other health conditions that make these treatments unsuitable. For those with ER-low, HER2-negative breast cancer, you must also be considered unsuitable for hormone therapy.

Finally, doctors need to be able to measure your cancer on scans like CT or MRI. You'll also need to meet other specific health requirements that the study team will discuss with you.

Quick self-check

Do you have advanced triple-negative breast cancer or ER-low, HER2-negative breast cancer?
Have you not received any prior treatment for your advanced cancer?
Are you unable to receive standard immunotherapy drugs (anti-PD(L)1)?
For ER-low, HER2-negative cancer, are you also unable to receive hormone therapy?
Are your cancer areas measurable by scans like CT or MRI?
Are you aged 18 or older?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be assigned to receive either the new drug, iza-bren, or one of several standard chemotherapy drugs. You will have regular visits to the hospital for treatment and check-ups. These visits will involve blood tests, physical examinations, and scans (like CT or MRI) to monitor your health and how the treatment is working. The specific frequency of visits and tests will depend on which treatment you receive.

The total duration of your participation in the study could vary. You will continue treatment for as long as it is benefiting you and you are tolerating it well. After treatment, there will be a follow-up period where the study team will continue to monitor your health and check on your progress. It's important to attend all scheduled appointments throughout the study period.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new experimental drug that could be more effective than existing treatments, or it might help contribute to scientific knowledge that benefits future patients. However, like all medications, iza-bren and standard chemotherapy drugs can have side effects, which could range from mild to severe. We don't yet know all the potential risks of iza-bren, but the medical team will monitor you closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (294)

Local Institution - 0303
Hot Springs, United States· Not yet recruiting
Helios Clinical Research
Cerritos, United States· Recruiting
Local Institution - 0307
Cerritos, United States· Withdrawn
Local Institution - 0308
Cerritos, United States· Withdrawn
Local Institution - 0309
Cerritos, United States· Withdrawn
Local Institution - 0311
Long Beach, United States· Withdrawn
USC/Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
Valkyrie Clinical Trials
Los Angeles, United States· Recruiting
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, United States· Recruiting
Local Institution - 0358
Stanford, United States· Not yet recruiting
Local Institution - 0289
Aurora, United States· Not yet recruiting
Rocky Mountain Cancer Centers
Denver, United States· Recruiting

+282 more sites — see the official record for the full list.

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer (TNBC) is a type of breast cancer where the cancer cells don't have common receptors for oestrogen, progesterone, or HER2 protein, making certain targeted therapies ineffective.

What does 'ineligible for anti-PD(L)1 drugs' mean?

It means that for medical reasons, you cannot receive certain immunotherapy drugs (like Keytruda or Tecentriq) that help your immune system fight cancer, either because they wouldn't work for your cancer type or due to other health issues.

What is iza-bren?

Iza-bren is a new experimental drug in this study. It's designed to deliver a cancer-fighting medicine directly to cancer cells by targeting two specific proteins on their surface.

Will I definitely receive the new drug?

No, participants in this study will be randomly assigned to receive either iza-bren or standard chemotherapy, so there's an equal chance of getting either treatment.

How long will I be in the study?

You will receive treatment for as long as it's effective and safe for you. After treatment, there will be a follow-up period to check on your long-term health.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.