Breast cancer, Triple negative tumor, stage III, Quality of Life Breast cancer, Triple negative tumor, stage III, Quality of Life
Conditions
Interventions
All participating patients will be asked to answer the HRQoL questionnaire (EORTCQLQ-C30, -BR23, -OH15), QoL questionnaire (EQ-5D-5L) and a symptom related questionnaire (FACT-ES) using the ‘SYMPRO 2.
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older Histologically confirmed adenocarcinoma of the breast Assumed clinical or pathological stage III (TNM) breast cancerBreast 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%.;Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise (preferably cohering with Dutch guideline recommended dose dense doxorubicin-cyclophosphamide (ddAC) plus carboplatin/paclitaxel (CbP)) followed by surgery and adjuvant radiotherapy. In case of no pathological complete response (no-pCR) adjuvant treatment with capecitabine is indicated for administration. Standard of care may change during the course of the study; e.g. patients harboring a gBRCA1/2m may receive adjuvant olaparib in case of no-pCR and pembrolizumab may be added to (neo-)adjuvant chemotherapy (see table 1 additional potential changes).Participating patients must be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language.
Exclusion criteria
Exclusion criteria: evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines. Patients who are only treated systemically in the adjuvant settingParticipation in another clinical study with a treatment intervention that is not yet indicated for this study population during the course of this study.Patients who are incapacitated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the HRQoL of patients with stage III TNBC treated with current standard (neo)adjuvant systemic therapy. Secondary objectives include 1) determining toxicity (including the effect on cognitive functioning and oral health quality related QoL), resource use, costs and outcomes of standard (neo)adjuvant systemic therapy for patients with stage III TNBC, 2) the course of dynamic ctDNA during standard of care (neo)adjuvant systemic therapy and its relation with treatment outcome in these patients and 3) comparing HRQoL outcomes determined in this study to the HRQoL results determined in the two experimental treatment strategies of the SUBITO study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include 1) determining toxicity (including cognitive functioning and oral health related QoL), resource use, costs and outcomes of standard of care (neo)adjuvant systemic therapy for patients with stage III TNBC, 2) the course of dynamic ctDNA during standard of care (neo)adjuvant systemic therapy and its relation with treatment outcome and 3) comparing the HRQoL outcomes for patients with stage III TNBC determined in this study to the HRQoL determined in the two experimental treatment strategies of the SUBITO study. | — |
Countries
Netherlands
Contacts
Public ContactP. Debets
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed