Phase IIIb Study of Ribociclib and Endocrine Therapy for Early Breast Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT05827081

Provider View

This study is testing the combination of ribociclib and standard hormone therapy to see if it can help prevent the return of early-stage breast cancer in patients with specific types of breast cancer.

Patient Parameters

Program Overview

The study aims to evaluate how effective and safe the combination of ribociclib and standard hormone therapy is in preventing the return of early-stage breast cancer. It focuses on patients with hormone receptor-positive, HER2-negative breast cancer at certain stages. The study is open-label, meaning both doctors and participants know what treatment is being given, and it takes place across multiple centers.

Description

The study includes three main parts: Screening, Treatment, and Follow-up.

  • Treatment Period: After completing the screening, participants will take ribociclib (400 mg) by mouth once daily for 21 days in a 28-day cycle, along with daily hormone therapy, for about 36 months. This period starts with the first dose of ribociclib and ends with a safety follow-up call 30 days after the last dose.

  • Follow-up Period: After finishing the treatment, participants will be monitored until they withdraw consent, are lost to follow-up, pass away, or until 48 months after the last participant starts treatment, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with breast cancer that is positive for estrogen or progesterone receptors.
  • Have HER2-negative breast cancer.
  • May have started standard hormone therapy up to 36 months before joining the study and should have at least 3 years of hormone therapy left.
  • No issues preventing the use of hormone therapy in the study.
  • Have had surgery to remove the tumor completely, with no cancer left in the surgical margins, and fall into one of these categories:
    • Stage III
    • Stage IIB
    • A specific subset of Stage IIA
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have adequate bone marrow and organ function.
  • Have specific heart function measurements within normal ranges.

Exclusion Criteria

  • Have breast cancer that has spread beyond nearby lymph nodes or has come back after surgery.
  • Currently using other cancer treatments besides hormone therapy.
  • Have any other severe or uncontrolled medical conditions.
  • Have significant, uncontrolled heart disease or heart rhythm problems.
  • Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Locations

FACILITYZIPCITYSTATE
Alaska Oncology and Hematology LLC99508AnchorageAlaska

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