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
- Conditions
- Metastatic HR positive, HER2 negative breast cancerTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504141-31-00
- Lead Sponsor
- Institut fuer Klinische Krebsforschung IKF GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Female patient has given written informed consent, Patients considered postmenopausal, 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
Patient has active (or history of) brain or leptomeningeal metastases, Patient has contraindication or shows hypersensitivity to the existing treatment with CDK4/6 inhibitor plus endocrine therapy, Patient is pre- or perimenopausal. Patient is pregnant or breast feeding or planning to become pregnant within five times the half-life of the IMP 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 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, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method