NCT06207734招募中2 期
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
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest13 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- Progression-free survival rate 12 months after randomization (PFS@12_stopping)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control arm CDK4/6 continuation
Active Comparator
- Continuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Continuation of CDK4/6 inhibitor Palbociclib (Drug)
Control arm CDK4/6 continuation
Active Comparator
- Continuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Continuation of CDK4/6 inhibitor -Palbociclib (Drug)
Control arm CDK4/6 continuation
Active Comparator
- Continuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Continuation of CDK4/6 inhibitor Abemaciclib (Drug)
Experimental arm CDK4/6 inhibitor discontinuation
Experimental
- Discontinuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Discontinuation of CDK4/6 inhibitor Palbociclib (Drug)
Experimental arm CDK4/6 inhibitor discontinuation
Experimental
- Discontinuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Discontinuation of CDK4/6 inhibitor -Palbociclib (Drug)
Experimental arm CDK4/6 inhibitor discontinuation
Experimental
- Discontinuation of CDK4/6 inhibitor treatment
- Continuation of endocrine treatment
干预措施: Discontinuation of CDK4/6 inhibitor Abemaciclib (Drug)
结局指标
主要结局
Progression-free survival rate 12 months after randomization (PFS@12_stopping)
时间窗: 12 months
Proportion of patients alive and without progression according to radiologic imaging assessment
次要结局
- Time to treatment failure (TTF2)(54 months)
- Progression-free survival (PFS)(54 months)
- Time to treatment failure (TTF)(54 months)
- Progression-free survival (PFS2)(54 months)
- Time to first use of chemotherapy(54 months)
- Quality of life (QoL) EORTC QLQ-C30(54 months)
- Quality of life (QoL) EORTC QLQ-BR23(54 months)
- Safety (rate of adverse events)(54 months)
研究者
研究点 (13)
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