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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | Up to 36 months after surgery |
| 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. | 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) | Up to 36 months after surgery |
| 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. | The HRQoL will be assessed through the following questionnaire: • Functional assessment of cancer therapy - endocrine symptoms (FACT-ES) | Up to 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Toxicity will be measured on a per-patient basis and assessed as a proportion of the total study population. | Up to 24 months after start treatment |
| Cognitive functioning - Questionnaire |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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Patients diagnosed with stage III, hormone receptor (HR)-negative HER2-negative, adenocarcinoma of the breast (TNBC).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pien Debets, Study coordinator | Contact | 0205129111 | p.debets@nki.nl | |
| Ingrid Mandjes, Clinical Projects Manager | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical spectrum Twente | Recruiting | Enschede | Overijssel | 7500 KA | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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blood samples for ctDNA (cirulating tumor)
Cognitive functioning will be measured using the cognitive functioning questionnaire at baseline and follow-up. This will be measured before and after standard (neo)adjuvant systemic therapy. |
| Up to 36 months after surgery |
| Cognitive functioning - ASC (Amsterdam Cognition Scan) | Cognitive functioning will be measured using the ASC (Amsterdam Cognition Scan) at baseline and follow-up. This will be measured before and after standard (neo)adjuvant systemic therapy. The ACS will determine the cognitive test performance through seven cognitive tests with 11 outcome measures. In this study the score differences in cognitive functioning between baseline and the two follow-up time points at 24 and 36 months after surgery will be calculated for patients treated with standard systemic therapy. | Up to 36 months after surgery |
| Oral health related quality of life (QoL) - EORTC-QLQ-OH15 | The EORTC-QLQ-OH15 will provide a detailed overview of oral health symptoms associated with cancer. The EORTC-QLQ-OH15 will be shortened to a 11-item questionnaire with a 4-point scoring scale defined by the terms: not at all, a little, quite a bit and very much. | Up to 36 months after surgery |
| Oral health related quality of life (QoL) - Xerostomia Inventory | The shortened Xerostomia Inventory will provide a detailed overview of oral health symptoms associated with cancer. The shortened Xerostomia Inventory includes 5 items with a 3-point scoring system defined by the terms: never, sometimes, always. | Up to 36 months after surgery |
| Oral health related quality of life (QoL) - Oral Impact on Daily Performance index | The Oral Impact on Daily Performance index will include 6 questions with a 6-point scoring system assessing the influence of oral health related problems on daily life functions. | Up to 36 months after surgery |
| Oral health related quality of life (QoL) - oral self-care questionnaire | The oral self-care questionnaire will provide further insights in the differences in oral care routines during follow-up. At baseline the self-care questionnaire will include 5 items compared to only 2 items at follow up. | Up to 36 months after surgery |
| Resource use - Dutch hospital data (DHD) | Resource use will be measured using the Dutch hospital data (DHD). The costs of the standard of care will be estimated using data on patient's treatments from the Dutch Hospital Database (DHD). These results will be implemented in a cost-effectiveness model. | Up to 36 months after surgery |
| Costs - Dutch hospital data (DHD) | Costs will be measured using the Dutch hospital data (DHD). The costs of the standard of care will be estimated using data on patient's treatments from the Dutch Hospital Database (DHD). These results will be implemented in a cost-effectiveness model. | Up to 36 months after surgery |
| Resource use - iMTA Medical Consumption Questionnaire (iMCQ) | Resource use will be measured using iMTA Medical Consumption Questionnaire (iMCQ). It is a not disease-specific questionnaire, which includes questions related to frequently occurring contacts with health care providers. | Up to 36 months after surgery |
| Resource use - iMTA Productivity Cost Questionnaire (iPCQ) | Resource use will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). The iMTA Productivity Cost Questionnaire (iPCQ) measures the impact of disease on the ability to perform work. | Up to 36 months after surgery |
| Overall survival (OS) | Number of patients alive and dead | Up to 36 months after surgery |
| Event-free survival | Number of patients with recurrence of disease | Up to 36 months after surgery |
| ctDNA dynamics | The levels of ctDNA at different time points will be assessed to determine ctDNA dynamic changes during standard of care (neo)adjuvant systemic therapy and their relation to treatment outcome. | Up to 36 months after surgery |
| Amsterdam University Medical Center | Not yet recruiting | Amsterdam | Netherlands |
| The Netherlands Cancer Institute | Recruiting | Amsterdam | Netherlands |
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| Amphia | Not yet recruiting | Breda | Netherlands |
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| UMCG | Recruiting | Groningen | 9713 GZ | Netherlands |
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| Maastricht University Medical Center | Recruiting | Maastricht | Netherlands |
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| ErasmusMC | Recruiting | Rotterdam | Netherlands |
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| D017437 |
| Skin and Connective Tissue Diseases |