CA2440008 - Comparison of BMS-986507 vs Doctor's Choice in Breast Cancer
Research type
Research Study
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
IRAS ID
1011930
Contact name
GSMCT Represenative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2024-519871-24
ISRCTN Number
none
Clinicaltrials.gov Identifier
Research summary
This clinical trial is testing a new drug, BMS-986507, to see how well it works and how safe it is for treating adults with advanced forms of a type of breast cancer called triple-negative breast cancer (TNBC) or a related type called estrogen receptor (ER)-low positive HER-2 negative breast cancer. These cancers are hard to treat, and many patients are ineligible for current drugs that use the immune system to target cancer. The study is comparing BMS-986507 to standard chemotherapy options chosen by the patient’s doctor. BMS-986507 targets specific proteins (EGFR and HER3) that help cancer grow, delivering a powerful anti-cancer drug directly to the tumour while sparing healthy cells.
The trial phases include:
• Phase 2: Tests two different doses of BMS-986507 to find the safest and most effective dose compared to the standard chemotherapy
• Phase 3: Confirms how well the selected dose works compared to standard chemotherapy.About 500 participants worldwide will join the study. Participants must have advanced or inoperable TNBC or ER-low positive, HER-2 negative breast cancer, must not have had prior treatment for their advanced cancer, and be unsuitable for immune-targeting drugs. Regular check-ups and imaging scans will monitor treatment effectiveness and safety.
The trial is open-label, so participants and doctors will know the treatment they receive. Sponsored by Bristol-Myers Squibb, it aims to offer new treatment options for patients with advanced TNBC who are not eligible for current therapies.
Participants must be at least 18. Participation is decided by the study doctor based on health, medical history, disease characteristics, and the absence of conditions or treatments that could affect study results. The study's main goals are to see if BMS-986507 can slow cancer progression, improve survival, and have manageable side effects. If successful, this new treatment could offer hope for patients with limited options today.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0108
Date of REC Opinion
16 Jul 2025
REC opinion
Further Information Favourable Opinion