Actively Recruiting
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-05-01
120
Participants Needed
13
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 signing informed consent
- Diagnosed with histologically confirmed metastatic adenocarcinoma of the breast
- Estrogen receptor positive (ER+) and HER2 negative (HER2-) disease confirmed by histology or cytology
- No curative treatment option available by surgery or radiotherapy
- Treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control (complete remission, partial remission, or stable disease)
- Preserved performance status (ECOG ≤ 2)
- Adequate bone marrow, renal, and hepatic function including hemoglobin > 9.0 g/dL, appropriate absolute neutrophil count, platelets ≥ 100 x 10^9/L, adequate creatinine clearance, AST/ALT and alkaline phosphatase ≤ 2.5x ULN, and serum albumin > 30 g/L
- Postmenopausal status defined by specific clinical criteria
- Women of childbearing potential 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 status, pregnancy, breastfeeding, or planning pregnancy within five times the half-life of study medication after treatment ends
- Significant cardiovascular disease including NYHA Class II or greater, recent myocardial infarction or cerebrovascular accident within 6 months, unstable arrhythmias, or unstable angina
- Other concurrent or prior malignancies except certain treated cancers in remission > 5 years
- Contraindication or hypersensitivity to CDK4/6 inhibitor plus endocrine therapy
- Any disease or condition that increases risk of treatment complications or affects study interpretation
- Participation in another investigational drug study within 28 days or 7 half-lives prior to treatment start
- Co-existing medical conditions increasing risk per investigator judgment
- History of incarceration or involuntary institutionalization by court or authorities
- Inability to consent due to lack of understanding of the clinical trial's nature and implications
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Charité Berlin
Berlin, Germany
Actively Recruiting
2
Hämatologische Onkologische Praxis im Medicum
Bremen, Germany
Actively Recruiting
3
St. Johannes Hospital Dortmund
Dortmund, Germany
Active, Not Recruiting
4
Praxis und Tagesklinik
Friedrichshafen, Germany
Active, Not Recruiting
5
Hausärztliche und Onkologische Gemeinschaftspraxis
Gerlingen, Germany
Actively Recruiting
6
Onkologische GP Gütersloh
Gütersloh, Germany
Active, Not Recruiting
7
Hämatologisch-Onkologische Praxis Altona
Hamburg, Germany
Actively Recruiting
8
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Actively Recruiting
9
MVZ für Hämatologie und Onkologie der MVZ Mülheim GmbH
Mülheim, Germany
Actively Recruiting
10
MVZ für Hämatologie und Onkologie
Ravensburg, Germany, 88212
Actively Recruiting
11
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
Actively Recruiting
12
Onkologisch-Gastroenterologische Schwerpunktpraxis Innere Medizin GbR
Singen, Germany, 78224
Actively Recruiting
13
Onkologiezentrum Soest-Iserlohn
Soest, Germany, 59494
Actively Recruiting
Research Team
T
Thomas Decker, Prof.
CONTACT
R
Regina Eickhoff, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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