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Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

NCT05452213 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-04-18

No results posted yet for this study

Summary

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

Conditions

Interventions

DRUG

Ribociclib

All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.

Sponsors & Collaborators

  • AGO Breast Study Group e.V.

    collaborator UNKNOWN

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Institut fuer Frauengesundheit

    lead OTHER

Principal Investigators

  • Peter A. Fasching, MD, Prof. · Department of Gynecology and Obstetrics, Erlangen University Hospital

  • Tanja Fehm, MD, Prof. · Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany

  • Andreas Schneeweiss, MD, Prof. · National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2024-10-31
Completion
2026-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT05452213 on ClinicalTrials.gov