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Study details
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[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant

Novartis Pharmaceuticals
NCT IDNCT05870579ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

48

Study length

about 8.2 years

Ages

18–100

Locations

6 sites in CA, KS, PA +2

About this study

This trial is testing the recommended dose of [177Lu]Lu-NeoB when used with ribociclib and fulvestrant for people with advanced breast cancer that has returned after treatment or progressed while being treated. The goal is to determine how much [177Lu]Lu-NeoB is safe and effective in this setting.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Goserelin
  • 2.Take Fulvestrant
  • 3.Take Ribociclib
  • +2 more
PhasePhase 1
DrugFulvestrant
Routeinjection
Primary goalIncidence and nature of DLTs during the DLT observation period

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low11%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

fulvestrant, goserelin, ribociclib

Drug routes

injection, oral (Oral Tablet)

Endpoints

Primary: Incidence and nature of DLTs during the DLT observation period, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Secondary: Clinical Benefit Rate (CBR), Duration of Response (DoR), Incidence and severity of AEs following [68Ga]Ga-NeoB administration, Objective Response Rate (ORR), Observed maximum blood concentration (Cmax) of [177Lu]Lu-NeoB, Overall Survival (OS), Progression Free Survival (PFS), Terminal elimination half-life (T^1/2) of [177Lu]Lu-NeoB

Body systems

Oncology