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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Capecitabine (Primary) ; Gallium 68 NeoBOMB1 (Primary) ; Lutetium-177 NeoBOMB1 (Primary)
  • Indications Breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NeoB-Cap1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 01 Jul 2024 Planned initiation date changed from 16 May 2024 to 21 Jun 2024.
    • 01 Jul 2024 Status changed from not yet recruiting to recruiting.
    • 20 Jun 2024 Recruitment completion is expected on 21 Jun 2026, according to ISRCTN: Current Controlled Trials.

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