A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06311383
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • First-line Ribociclib + endocrine therapy — DRUG
    Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
  • First-line endocrine therapy — DRUG
    As of physicians choice
  • First-line chemtherapy — DRUG
    As of physicians choice

Study Details

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Key Dates

Start date
Oct 9, 2017
Status verified
Jan 2026
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025

Study Design

Enrollment
2,610 participants (actual)

Arms

  • Arm: First-line Ribociclib + endocrine therapy
    Ribociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
  • Arm: First-line endocrine therapy
    As of physicians choice
  • Arm: First-line chemotherapy
    As of physicians choice

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 88 months ]

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