A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 504
- 主要终点
- Primary outcome
研究概览
简要总结
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer
详细描述
Study design and setting We will conduct an international, multicentre, open-label, randomised controlled trial. All oncological departments who treat patients with metastatic breast cancer can participate. The EU Clinical Trial Regulation will be applied.
Interventions Trial participants will be randomised to trastuzumab deruxtecan or standard treatment.
Trastuzumab deruxtecan
Patients randomised to trastuzumab deruxtecan will be treated as:
Trastuzumab deruxtecan until progression or intolerable toxicity, Trastuzumab deruxtecan: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.
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
- •Women aged 18 or above.
- •Radiologically/pathologically verified metastatic breast cancer.
- •ER-positive (1% or more) and HER2-low (HER2 1+ or HER2 2+/ISH-neg)10,
- •PAM50 Luminal B, HER2-enriched or Basal-like.
- •Performance status 0-
- •Evaluable disease
排除标准
- •Patients who are incapable of understanding the written material received
- •Patients with inaccessible tumour tissue
- •Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)
研究组 & 干预措施
Trastuzumab-deruxtecan
Trastuzumab deruxtecan until progression or intolerable toxicity: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.
干预措施: Trastuzumab deruxtecan (T-DXd) (Drug)
Immunohistochemistry guided treatment (standard)
- CDK4/6 inhibitor with an endocrine therapy until progression og intolerable toxicity
- CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 4 week schedule) or abemaciclib (125mg twice daily).
- Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)
干预措施: Ribociclib with ET (Drug)
Immunohistochemistry guided treatment (standard)
- CDK4/6 inhibitor with an endocrine therapy until progression og intolerable toxicity
- CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 4 week schedule) or abemaciclib (125mg twice daily).
- Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)
干预措施: Abemaciclib with ET (Drug)
结局指标
主要结局
Primary outcome
时间窗: Up to 4 years after inclusion
Progression-free survival (ITT)
次要结局
- Overall survival(Up to 4 years after inclusion)
- PFS by subtype(Up to 4 years after inclusion)
- OS by subtype(Up to 4 years after inclusion)
- Quality of life(During treatment, estimated 18-24 months)
- Toxicity(During treatment, estimated 18-24 months)
研究者
Tobias Berg
MD
Danish Breast Cancer Cooperative Group