Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Trial Details

NCT ID
NCT05827081
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Ribociclib
  • Letrozole
  • Ansastrozole
  • Goserelin
  • Leuprolide
  • Exemestane
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Beverly Hills, California, United States|34.07362,-118.40036

Key Eligibility Criteria

  • Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).
  • Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breas…
  • Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a n…
  • Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed conse…

For full eligibility, visit ClinicalTrials.gov.

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