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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

NCT06311383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2610

Last updated 2026-01-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

First-line Ribociclib + endocrine therapy

Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant

DRUG

First-line endocrine therapy

As of physicians choice

DRUG

First-line chemtherapy

As of physicians choice

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2025-03-10
Completion
2025-03-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311383 on ClinicalTrials.gov