[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (NCT05870579)
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocrine Therapy or Who Have Progressed on Endocrine Therapy in Combination With a CDK4/6 Inhibitor for Advanced Disease
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease.
Who can join: Review the eligibility criteria below.
Location: UCLA Jonsson Comp Cancer Center — Los Angeles, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- UCLA Jonsson Comp Cancer Center — Los Angeles, California
- MD Anderson Cancer Center — Houston, Texas
- Novartis Investigative Site — Shanghai,
- Novartis Investigative Site — Saint-Cloud, Hauts De Seine
- Novartis Investigative Site — Bordeaux,
- Novartis Investigative Site — Saint-Herblain,
- Novartis Investigative Site — Cologne, North Rhine-Westphalia
- Novartis Investigative Site — Gliwice,
- Novartis Investigative Site — Porto,
- Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona
- Novartis Investigative Site — Barcelona,
- Novartis Investigative Site — Madrid,
- Novartis Investigative Site — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.