Status:
RECRUITING
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
Lead Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Female patient has given written informed consent
- Patient is ≥ 18 years of age at time of signing the written informed consent
- Patient has been diagnosed with histologically confirmed metastatic adenocarcinoma of the breast
- Patient has documented histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative (HER2-) disease
- Patient has no curative treatment option by surgery or radiotherapy
- Patient was treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control (complete remission, partial remission or stable disease) as judged by the treating physician before planned study treatment initiation
- Patient has a preserved performance status (ECOG ≤ 2)
- Patient has adequate bone marrow, renal and hepatic function:
- Hemoglobin \> 9.0 g/dL
- Absolute neutrophil count judged as appropriate for study therapy by the investigator
- Platelets ≥ 100 x 109/L
- Calculated creatinine clearance judged as appropriate for study therapy by the investigator
- AST (SGOT) / ALT (SGPT) and alkaline phosphatase ≤ 2.5x ULN
- Serum albumin \> 30 g/L
- Patients considered postmenopausal according to one of the following definition:
- Women \<50 years of age who are amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and whose levels of luteinizing hormone and follicle-stimulating hormone are in the post-menopausal institutional range
- Women ≥50 years of age who are amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago or had chemotherapy-induced menopause with last menses \>1 year ago
- Artificially induced postmenopausal women (by Gonadotropin-releasing hormone \[GnRH\] analogs)
- WOCBP must have a negative serum pregnancy test within 7 days prior to start of trial
Exclusion
- Patient has active (or history of) brain or leptomeningeal metastases
- Patient is pre- or perimenopausal. Patient is pregnant or breast feeding or planning to become pregnant within five times the half-life of the IMPs after the end of treatment.
- Patient has significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 6 months prior to initiation of study treatment, unstable arrhythmias, or unstable angina
- Patient has other concomitant or previous malignancy, except adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, cancer in complete remission for \> 5 years
- Patient has contraindication or shows hypersensitivity to the existing treatment with CDK4/6 inhibitor plus endocrine therapy
- Patient shows evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results
- Patient participated in another clinical study with an investigational medicinal product during the last 28 days before treatment initiation or 7 half-lives of previously used trial medication, whichever is longer or participate in such a study at the same time as this trial.
- Note: Participation in non-interventional clinical studies or registries is allowed.
- Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06207734
Start Date
January 17 2024
End Date
July 10 2028
Last Update
May 1 2025
Active Locations (13)
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1
Charité Berlin
Berlin, Germany
2
Hämatologische Onkologische Praxis im Medicum
Bremen, Germany
3
St. Johannes Hospital Dortmund
Dortmund, Germany
4
Praxis und Tagesklinik
Friedrichshafen, Germany