Trial comparing treatments for Breast Neoplasms
Official title 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)
ClinicalTrials.gov ID: NCT06926868
What this study is testing
What is Iza-bren?
Iza-bren is an investigational medicine, being studied as a potential treatment for breast neoplasms.
Also referred to as BMS-986507, BL-B01D1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new drug iza-bren is more effective and safe than standard chemotherapy options for treating this type of breast cancer.
- Who it's for
- The study is looking for people with advanced triple-negative breast cancer who have not started treatment yet and cannot use certain immune therapy drugs.
- What's involved
- Participants will receive either the new drug iza-bren or a standard chemotherapy plan chosen by their doctor, along with regular medical checks and tests.
- Time commitment
- The study involves ongoing treatment and regular visits to the clinic until the cancer grows or the treatment is stopped.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC)...
- Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
- Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1...
- 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).
You likely can't join if
- Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a...
- Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants'...
- Leptomeningeal metastases.
- Participants with history of severe heart disease including, but not limited to, any of the following: i) History of clinically significant heart...
- Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.
- Other protocol-defined Inclusion/Exclusion criteria apply.
See the full eligibility criteria
- Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2...
- Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
- Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria: i)...
- 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.
- Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi).
- Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline.
- Leptomeningeal metastases.
- Participants with history of severe heart disease including, but not limited to, any of the following: i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart...
- Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Cerritos, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Denver, Colorado, United States
- Newark, Delaware, United States
- Atlanta, Georgia, United States
- Decatur, Illinois, United States
- Covington, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Maple Grove, Minnesota, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Westbury, New York, United States
- White Plains, New York, United States
- Durham, North Carolina, United States
- Eugene, Oregon, United States
- Allentown, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Greenville, South Carolina, United States
+ 129 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cerritos, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Denver, Colorado, United States; Newark, Delaware, United States; Atlanta, Georgia, United States and 143 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.