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Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

NCT04055493 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1684

Last updated 2026-05-11

No results posted yet for this study

Summary

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

Conditions

  • Breast Cancer Female

Interventions

DRUG

Ribociclib 200Mg Oral Tablet

3 x 200 MG per os

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genomic Health®, Inc.

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Nadia Harbeck, Prof. Dr. · Ludwigs-Maximilians-University Munich, Breast Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Germany

Study Locations

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Entities

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 NCT04055493 on ClinicalTrials.gov