In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).
Age range
18 Years – 100 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase I: Incidence and severity of dose limiting toxicities (DLTs)
Timeframe: 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
Timeframe: 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
Timeframe: From start of study treatment until the last dose of study treatment, assessed up to approximately 31 months
Phase II: Objective Response Rate (ORR)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: From the date of first dose until date of death from any cause, assessed up to approximately 88 months