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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

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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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; Gallium 68 NeoBOMB1 (Primary) ; Goserelin (Primary) ; Lutetium-177 NeoBOMB1 (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 14 Feb 2025 Planned End Date changed from 30 Dec 2031 to 26 Jan 2032.
    • 20 Dec 2024 Planned End Date changed from 26 Dec 2031 to 30 Dec 2031.
    • 18 Jul 2024 Planned primary completion date changed from 26 Dec 2031 to 30 Dec 2026.

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