Actively Recruiting
Discontinuation of CDK46 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer With Durable Disease Control A Randomized Low-intervention Phase II Trial
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-05-01
120
Participants Needed
13
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of stopping CDK46 inhibitors in women with metastatic hormone receptor HR positive, HER2 negative breast cancer who have maintained disease control after long-term treatment. This phase II trial aims to evaluate whether disease stability continues when CDK46 inhibitors are discontinued after at least 12 months of combined treatment with endocrine therapy. The study is open-label, randomized, and conducted at multiple centers. Participants are randomly assigned to one of two groups one group continues both CDK46 inhibitor treatment such as Palbociclib or Abemaciclib and endocrine therapy, while the other group discontinues the CDK46 inhibitor but continues endocrine therapy alone. The study monitors disease progression and treatment effects over time, with a focus on how long patients remain free from disease worsening after stopping the CDK46 inhibitor. During the study, participants will be regularly assessed for disease progression, safety, and quality of life using questionnaires and clinical evaluations. Researchers will measure progression-free survival at 12 months and up to 54 months, time to treatment failure, time to first chemotherapy use, and monitor adverse events. The total participation duration may extend beyond four years, with ongoing evaluations to understand long-term outcomes and safety after stopping the CDK46 inhibitor.
CONDITIONS
Brief Title
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient has given written informed consent
- Patient is 18 years of age or older at time of consent
- Diagnosed with histologically confirmed metastatic adenocarcinoma of the breast
- Histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative disease
- No curative treatment option by surgery or radiotherapy
- Treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control
- Preserved performance status (ECOG ≤ 2)
- Adequate bone marrow, renal, and hepatic function as judged by specified lab values
- Postmenopausal status by defined criteria
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to trial start
You will not qualify if you...
- Active or history of brain or leptomeningeal metastases
- Pre- or perimenopausal, pregnant, breastfeeding, or planning pregnancy within five times the half-life of the investigational medicinal products after treatment ends
- Significant cardiovascular disease or recent major cardiac events
- Other cancers except certain treated in-situ or skin carcinomas or cancers in remission over 5 years
- Contraindication or hypersensitivity to current CDK4/6 inhibitor plus endocrine therapy
- Any other disease or condition that contraindicates study medications or increases risk
- Participation in another clinical study with investigational medicinal product within 28 days or 7 half-lives prior to treatment
- Co-existing medical condition increasing risk per investigator's judgment
- History of incarceration or involuntary institutionalization
- Unable to consent due to lack of understanding of the trial nature and implications
Research Team
T
Thomas Decker, Prof.
R
Regina Eickhoff, Dr.
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