A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Phase I: Incidence and severity of dose limiting toxicities (DLTs)

  Measured over: 42 days after the first administration of [177Lu]Lu-NeoB

• Phase I: Incidence and severity of adverse events and serious adverse events for 177-Lu-NeoB in combination with capecitabine

  Measured over: From start of study treatment until 56 days after the last dose of study treatment, assessed up to approximately 33 months

• Phase I: Dose modifications for [177Lu]Lu-NeoB in combination with capecitabine

  Measured over: From start of study treatment until the last dose of study treatment, assessed up to approximately 31 months

• Phase II: Objective Response Rate (ORR)

  Measured over: From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

• Phase II: Clinical Benefit Rate (CBR)

  Measured over: From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

• Phase II: Time to Response (TTR)

  Measured over: From date of randomization until first documented evidence of CR or PR (the response prior to confirmation), assessed up to approximately 88 months

• Phase II: Duration of Response (DoR)

  Measured over: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

• Phase II: Progression Free Survival (PFS)

  Measured over: From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

• Phase II: Overall Survival (OS)

  Measured over: From the date of first dose until date of death from any cause, assessed up to approximately 88 months

Changes Tremor has spotted