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. (NCT06247995)
A Phase I/II, Open-label, Multi-center Trial 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.
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: UCLA Medical 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 (23 Sites)
- UCLA Medical Center — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Mayo Clinic - Rochester — Rochester, Minnesota
- Uni Of TX MD Anderson Cancer Cntr — Houston, Texas
- University Of Wisconsin — Madison, Wisconsin
- Novartis Investigative Site — Darlinghurst, New South Wales
- Novartis Investigative Site — Malvern, Victoria
- Novartis Investigative Site — Toronto, Ontario
- Novartis Investigative Site — Montreal, Quebec
- Novartis Investigative Site — Tianjin,
- Novartis Investigative Site — Grenoble,
- Novartis Investigative Site — Saint-Herblain,
- Novartis Investigative Site — Villejuif,
- Novartis Investigative Site — Erlangen,
- Novartis Investigative Site — Tübingen,
- Novartis Investigative Site — Delft, South Holland
- Novartis Investigative Site — Porto,
- Novartis Investigative Site — Singapore,
- Novartis Investigative Site — Seoul,
- Novartis Investigative Site — Seoul,
- Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona
- Novartis Investigative Site — Barcelona,
- 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.