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IZABRIGHT-Breast01:Izalontamab Brengitecan(BMS-986507)vs Tx of Physician's Choice - Clinical Trial

¿Cuál es el Propósito de este estudio?

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

¿Cuál es la Condición que se está estudiando?

Adults with advanced solid tumors

¿Quién puede participar en el Estudio?

¿Quién puede participar en este estudio?

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

Grupo etario
Adultos

¿Qué Implica?

¿Por qué se está llevando a cabo este estudio?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Carey K. Anders, MD
Especialista en oncología médica
Número de Protocolo
IRB: PRO00118600
NCT: NCT06926868
Fase
Phase II/III
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health