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Compares treatment options 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
- 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.
- 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 TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0...
- 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...
- 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
- apply.
See the full eligibility 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...
- 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...
- 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/
- apply.
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Cerritos, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Newark, Delaware, United States
- Pembroke Pines, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- O'Fallon, Illinois, United States
- Covington, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Maple Grove, Minnesota, United States
- Minneapolis, Minnesota, United States
+ 232 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 - 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?
Study sites include Hot Springs, Arkansas, United States; Cerritos, California, United States; Long Beach, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Stanford, California, United States and 246 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.