Purpose of this Study
This study has 3 parts:
1. Screening - Lasts up to 28 days. You'll get heart tests, scans, and blood and urine tests.
2. Treatment - You'll be randomly picked to get either a new medicine (iza-bren) or a cancer medicine your doctor chooses. You'll visit the clinic 2-3 times every few weeks.
3. Follow-up - After treatment ends, you'll have:
- A safety check 30 days later
- Regular checkups every 12 weeks
- More tests like scans and heart checks
Who Can Participate?
Eligibility
Who can join this study?
Adults with a kind of advanced breast cancer called Triple-Negative Breast Cancer (TNBC) can join if:
- Their cancer is confirmed and has spread or come back and can’t be removed with surgery
- Their cancer came back at least 6 months after their last treatment
- Their cancer came back 6 to 12 months after getting a special kind of treatment called anti-PD(L)1 therapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
Why is this study happening?
Doctors want to find out if a new medicine called iza-bren helps people with a certain kind of breast cancer called Triple-Negative Breast Cancer (TNBC) or ER-low breast cancer—especially for those who can’t get treatments like immunotherapy or hormone therapy.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
Carey
Anders
Protocol Number
PRO00118600
NCT ID
NCT06926868
Phase
II/III
Enrollment Status
Pending Open to Enrollment