[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) 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.

Trial Details

NCT ID
NCT05870579
Phase
PHASE1
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • [68Ga]Ga-NeoB
  • [177Lu]Lu-NeoB
  • Ribociclib
  • Fulvestrant
  • Goserelin
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895
  • Westwood, Kansas, United States|39.04056,-94.6169
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Adult female or male \>= 18 years of age at the time of informed consent
  • Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive with ER \>10% (regardless of progesterone receptor (PgR) expr…
  • HER2 negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, …
  • Participant has advanced (loco regionally recurrent not amenable to curative therapy (e.g. surgery and/or radiotherapy) or metastatic) breast cancer

For full eligibility, visit ClinicalTrials.gov.

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