Trial details
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
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Trial short name: CAAA603
Official title: 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
Principal Investigator: Dr. Katarzyna Jerzak
Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase: Phase 1, Phase 2
Intervention: Drug: [68Ga]Ga-NeoB, Drug: [177Lu]Lu-NeoB, Drug: Capecitabine
Registration #:
NCT06247995 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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).
