TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 1.
研究概览
简要总结
This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at nine time points during and after their anticancer treatment in a mobile application.
For all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Histologically confirmed adenocarcinoma of the breast
- •Assumed clinical or pathological stage III (TNM) breast cancer
- •Breast tumor must be:
- •HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)
- •Hormone receptor negative i.e. an estrogen receptor (ER) of <10% and progesterone receptor (PR) of <10%.; or in case of a histological grade III tumor an ER of <50% and a PR of <50%.
- •Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise
- •Participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language
排除标准
- •Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.
- •Patients who are only treated systemically in the adjuvant setting
- •Participation in another clinical study with an treatment intervention during the course of this study.
结局指标
主要结局
To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 1.
时间窗: Up to 36 months after surgery
The HRQoL will be assessed through the following questionnaire: • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ C30)
To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 2.
时间窗: Up to 36 months after surgery
The HRQoL will be assessed through the following questionnaire: • European Organization for Research and Treatment of Breast Cancer specific Quality of Life Questionnaire (EORTC QLQ BR23)
To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 3.
时间窗: Up to 36 months after surgery
The HRQoL will be assessed through the following questionnaire: • Functional assessment of cancer therapy - endocrine symptoms (FACT-ES)
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 24 months after start treatment)
- Cognitive functioning - Questionnaire(Up to 36 months after surgery)
- Cognitive functioning - ASC (Amsterdam Cognition Scan)(Up to 36 months after surgery)
- Oral health related quality of life (QoL) - EORTC-QLQ-OH15(Up to 36 months after surgery)
- Oral health related quality of life (QoL) - Xerostomia Inventory(Up to 36 months after surgery)
- Oral health related quality of life (QoL) - Oral Impact on Daily Performance index(Up to 36 months after surgery)
- Oral health related quality of life (QoL) - oral self-care questionnaire(Up to 36 months after surgery)
- Resource use - Dutch hospital data (DHD)(Up to 36 months after surgery)
- Costs - Dutch hospital data (DHD)(Up to 36 months after surgery)
- Resource use - iMTA Medical Consumption Questionnaire (iMCQ)(Up to 36 months after surgery)
- Resource use - iMTA Productivity Cost Questionnaire (iPCQ)(Up to 36 months after surgery)
- Overall survival (OS)(Up to 36 months after surgery)
- Event-free survival(Up to 36 months after surgery)
- ctDNA dynamics(Up to 36 months after surgery)