MedTrace Logo

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

NCT03905343 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-06-16

No results posted yet for this study

Summary

The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).

Conditions

Interventions

DRUG

Ribociclib

Ribociclib 600mg p.o. d1-21, q4w in combination with endocrine treatment for 3 years.

OTHER

Mono-chemotherapy

mono-chemotherapy for at least 12 weeks (afterwards, maintenance endocrine therapy ± ribociclib inhibitor is allowed) and up to 3 years.

OTHER

Endocrine-Therapy

The choice of endocrine therapy is up to the investigator, but the chosen endocrine therapy has to be registered to be used in combination with ribociclib in the investigated indication.

Sponsors & Collaborators

  • The Belgian Society of Medical Oncology

    collaborator OTHER

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Thomas Ruhstaller, Prof · Kantonsspital St. Gallen - Breast Center St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • Austria
  • Belgium
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03905343 on ClinicalTrials.gov