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 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).

Trial Details

NCT ID
NCT06247995
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • [68Ga]Ga-NeoB
  • [177Lu]Lu-NeoB
  • Capecitabine
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Houston, Texas, United States|29.76328,-95.36327
  • Madison, Wisconsin, United States|43.07305,-89.40123

Key Eligibility Criteria

  • Signed informed consent must be obtained prior to participation in the study.
  • Participant is female or male adult ≥ 18 years old at the time of informed consent(s).
  • Participant has a histologically and/or cytologically documented diagnosis of ER+ breast cancer (ER expression \>10% of tumor cell nuclei stain (re…
  • Participant has HER2-negative (as per ASCO-CAP guidelines Wolff et al 2018) breast cancer defined as a negative in situ hybridization test (ISH) or…

For full eligibility, visit ClinicalTrials.gov.

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