A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab Combined With Chemotherapy or Endocrine Therapy.
详细描述
This is a non-inferiority study to examine Trastuzumab combined with chemotherapy or endocrine therapy in patients with metastatic Luminal B2 breast cancer subtype. The main purposes of this study are to test the safety and clinical benefit of Trastuzumab combined with chemotherapy or endocrine therapy in treating Luminal B2 breast cancer (hormone receptor positive and human epidermal growth factor receptor (HER2) positive or amplification). This multicentre, randomized study is designed to recruit up to 392 subjects to identify 196 research subjects for each study 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or
- •Histologically confirmed metastatic or local recurrence of breast cancer.
- •ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.
- •Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.
- •Patients must have measurable or evaluable disease.
- •Adequate bone marrow reserve with neutrophils > 1000 and platelets > 100,
- •Adequate renal function with serum creatinine < 2.
- •Adequate hepatic reserve with serum bilirubin < 2.0, alanine transaminase(ALT) < 3 times the upper limit of normal, and alkaline phosphatase < 5 times the upper limit of normal.
- •Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.
- •Able to give informed consent.
- •Life expectancy of at least 12 weeks.
排除标准
- •Pregnant or breast feeding.
- •ECOG score ≧2
- •DFI <12 months.
- •LVEF < 45% by echocardiogram.
- •Uncontrolled medical problems.
- •Evidence of active acute or chronic infection.
- •Hepatic, renal, or bone marrow dysfunction as detailed above.
- •Concurrent malignancy or history of other malignancy within the last five years except as noted above.
- •Known severe hypersensitivity to Trastuzumab.
- •Patients were unable or unwilling to comply with program requirements.
研究组 & 干预措施
Palliative chemotherapy
Chemotherapy combined with trastuzumab. Chemotherapy could use the following drugs such as capecitabine , Vinorelbine, or Gemcitabine.
干预措施: Chemotherapy combined with trastuzumab (Drug)
Palliative endocrine therapy
Endocrine therapy combined with trastuzumab. Endocrine therapy could use tamoxifen or aromatase inhibitors including anastrozole, letrozole, or exemestane.
干预措施: Endocrine therapy combined with trastuzumab (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 36 months
The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
unYat-senU
Sun Yat-sen University