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Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer

NCT06207734 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-01

No results posted yet for this study

Summary

This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer with durable disease control.

Conditions

Interventions

DRUG

Continuation of CDK4/6 inhibitor Palbociclib

Continuation of CDK4/6 inhibitor Palbociclib

DRUG

Discontinuation of CDK4/6 inhibitor Palbociclib

Discontinuation of CDK4/6 inhibitor Palbociclib

DRUG

Continuation of CDK4/6 inhibitor -Palbociclib

Continuation of CDK4/6 inhibitor -Palbociclib

DRUG

Discontinuation of CDK4/6 inhibitor -Palbociclib

Discontinuation of CDK4/6 inhibitor -Palbociclib

DRUG

Continuation of CDK4/6 inhibitor Abemaciclib

Continuation of CDK4/6 inhibitor Abemaciclib

DRUG

Discontinuation of CDK4/6 inhibitor Abemaciclib

Discontinuation of CDK4/6 inhibitor Abemaciclib

Sponsors & Collaborators

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof. · Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2027-01-10
Completion
2028-07-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT06207734 on ClinicalTrials.gov