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Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

NCT03555877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-07-07

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at least stable disease) after 1st line chemotherapy.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Ribociclib

Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib.

DRUG

Anastrozole

1mg once daily as indicated in the SmPC

DRUG

Letrozole

2,5mg once daily as indicated in the SmPC

DRUG

Exemestane

25mg once daily as indicated in the SmPC

DRUG

Fulvestrant

(prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC

Sponsors & Collaborators

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Thomas Decker, Prof. Dr. · Gemeinschaftspraxis Onkologie Ravensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2022-07-21
Completion
2022-07-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT03555877 on ClinicalTrials.gov