Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients: A Cohort Study of Patients Treated Either With Docetaxel and Trastuzumab or Docetaxel, Trastuzumab and Pertuzumab
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 37
- 主要终点
- progression free survival rate
研究概览
简要总结
Despite the clear benefit of a combination therapy of pertuzumab plus trastuzumab plus docetaxel when compared with a combination therapy of trastuzumab and docetaxel the study populations of the CLEOPATRA trial might be slightly different from a patient population, in which pertuzumab, plus trastuzumab plus chemotherapy or trastuzumab plus chemotherapy are applied in routine clinical practice.
This non-interventional approach aims to confirm the clinically relevant outcomes shown in the phase III CLEOPATRA study in patients with advanced HER2-positive breast cancer in routine practice. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.
Data on efficacy, safety, tolerability and quality of life will be documented for this purpose. Following the recommendations as laid down in guidelines for treatment of breast cancer, the quality of life of patients will be assessed on a regular basis.
详细描述
Breast cancer is the commonest cancer in women worldwide with an estimated 1.4 million new diagnoses in 2008 and 1.6 million cases estimated for 2015. In 2008 breast cancer was responsible for approximately 23% of all new cancer diagnoses in women. It is also the commonest cause of cancer deaths in women worldwide: in 2008 some 458,500 women died from breast cancer, with a further 538,500 projected for 2015.
In developed countries most breast cancers (in 94%-95% of patients in the EU and USA) are diagnosed while the tumour is confined to the breast - with or without locoregional lymph node involvement. At this early breast cancer (EBC) stage the disease is normally operable and can be treated curatively. Metastatic breast cancer (MBC) is less common and occurs in 5%-6% of newly diagnosed cases. Despite advances in the treatment of EBC approximately 30% of women develop local recurrence or metastases. In the USA and Europe patients with MBC survive for a mean 24 months and have a 5 year survival rate of 18%-23%.
Between 18% and 20% of breast cancers show HER2 amplification and/or HER2 receptor overexpression. Such patients have a poor prognosis on conventional treatment. The HER2 receptor is a protein belonging to the epidermal growth factor receptor (EGFR) family. The HER family consists of four structurally similar receptors - HER1/EGFR, HER2, HER3, HER4 - and regulates cell processes such as differentiation, invasion, proliferation, neoangiogenesis, survival and metastatic potential. In breast cancer HER2 positivity is associated with more aggressive tumours, higher relapse rates, lower and shorter treatment response and increased mortality.
Systemic treatment options in MBC include chemotherapy along with hormonal and targeted approaches. Tumor properties and patient-specific factors determine the choice of treatment.
In HER2-positive MBC trastuzumab for many years was the reference first-line treatment. Treatment-naive HER2-positive patients with MBC treated with trastuzumab and taxane chemotherapy showed significantly longer median time to progression (TTP), higher objective response rates (ORR) and longer median response and median survival than patients treated with chemotherapy alone. Although trastuzumab has proved effective in combination with chemotherapy in the first-line treatment of patients with HER2-positive MBC, approximately 50% of patients experience disease progression within one year of starting treatment. Mean survival in HER2-positive patients in the pivotal studies of trastuzumab in combination with a taxane was 24.8 and 31.2 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult breast cancer patients (age ≥18 years)
- •Patients with metastatic or locally advanced, unresectable HER2-positive breast cancer proven by clinical measures (i.e. standard imaging) in first line treatment (Locally recurrent disease must not be amenable to resection with curative intent)
- •Patients who are eligible for treatment with trastuzumab plus chemotherapy or pertuzumab plus trastuzumab plus chemotherapy as first line therapy, administered intravenously in a three weekly frequency, according to each center's medical practice. The first line anti-HER2 treatment must not have started more than 28 days before study entry.
- •No prior chemotherapy or HER2-directed therapy for metastatic or locally advanced disease, prior therapy for early breast cancer (eBC) is allowed
- •Signed informed consent prior to onset of documentation.
排除标准
- •Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
结局指标
主要结局
progression free survival rate
时间窗: At 12 months or month 36
The primary objective of this study is to assess the progression free survival rate at month 12 for both treatment cohorts in routine clinical practice treated with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel.
次要结局
- Overall response rate(Timepoint of progression or month 36)
- Quality of life (EORTC QLQ-BR23)(At 12 months)
- Quality of life (EORTC QLQ-C30)(At 12 months)
- Incidence of adverse events and serious adverse events will be documented(up 36 month)
- Progression free survival(Timepoint of progression or month 36)