[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant
Phase 1
48
about 8.2 years
18–100
6 sites in CA, KS, PA +2
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Goserelin
- 2.Take Fulvestrant
- 3.Take Ribociclib
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fulvestrant, goserelin, ribociclib
injection, oral (Oral Tablet)
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
Oncology