Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG [68Ga]Ga-NeoB
- DRUG [177Lu]Lu-NeoB
Study Locations (20)
Other
- Novartis Investigative Site — Guangzhou
- Novartis Investigative Site — Tianjin
- Novartis Investigative Site — Bordeaux
- Novartis Investigative Site — Grenoble
- Novartis Investigative Site — Saint-Herblain
- Novartis Investigative Site — Strasbourg
- Novartis Investigative Site — Villejuif
- Novartis Investigative Site — Erlangen
- Novartis Investigative Site — Essen
- Novartis Investigative Site — Tübingen
California
- UCLA Medical Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
Minnesota
- Mayo Clinic - Rochester — Rochester
Texas
- Uni Of TX MD Anderson Cancer Cntr — Houston
Wisconsin
- University Of Wisconsin — Madison
New South Wales
- Novartis Investigative Site — Darlinghurst
Victoria
- Novartis Investigative Site — Malvern
Ontario
- Novartis Investigative Site — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2031-09-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06247995
The ClinicalTrials.gov registry entry for NCT06247995 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06247995 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06247995 about?
NCT06247995 is a clinical study titled "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.". 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 ca...
What is the current status of trial NCT06247995?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2024-08-14. Estimated completion is 2031-09-09.
What conditions does trial NCT06247995 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06247995?
The interventions under investigation include: Capecitabine (DRUG), [68Ga]Ga-NeoB (DRUG), [177Lu]Lu-NeoB (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06247995?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06247995 being conducted?
This trial has 20 study locations across California, Minnesota, Texas, Wisconsin, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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