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.
Patients aged 18 years or older
Histologically confirmed adenocarcinoma of the breast
Assumed clinical or pathological stage III (TNM) breast cancer
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)
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.
Patients diagnosed with stage III, hormone receptor (HR)-negative HER2-negative, adenocarcinoma of the breast (TNBC).
Cohort
Prospective
Not listed
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)
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)
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)
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.
Cognitive functioning - Questionnaire
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.
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.
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.
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The Netherlands Cancer Institute
Lead sponsor
Dutch Cancer Society
Collaborator
