NCT06207734

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

Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer With Durable Disease Control: A Randomized Low-intervention Phase II Trial of the AIO Working Groups Breast Cancer and Quality of Life

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to evaluate long-term disease stabilization of CDK4/6 inhibitors discontinuation after a prolonged treatment period with continued endocrine therapy in breast cancer patients exhibiting at least stable disease after at least 12 months of combination treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-17
• Primary completion: 2027-01-10
• Completion: 2028-07-10
• First posted: 2024-01-17
• Last updated: 2025-05-01

Locations

13 sites across 1 country: Germany