TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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. [Time frame: 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. [Time frame: 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. [Time frame: Up to 36 months after surgery]
Secondary outcome measures (12)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: Up to 24 months after start treatment]
- Cognitive functioning - Questionnaire [Time frame: Up to 36 months after surgery]
- Cognitive functioning - ASC (Amsterdam Cognition Scan) [Time frame: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - EORTC-QLQ-OH15 [Time frame: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - Xerostomia Inventory [Time frame: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - Oral Impact on Daily Performance index [Time frame: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - oral self-care questionnaire [Time frame: Up to 36 months after surgery]
- Resource use - Dutch hospital data (DHD) [Time frame: Up to 36 months after surgery]
- Costs - Dutch hospital data (DHD) [Time frame: Up to 36 months after surgery]
- Resource use - iMTA Medical Consumption Questionnaire (iMCQ) [Time frame: Up to 36 months after surgery]
- Resource use - iMTA Productivity Cost Questionnaire (iPCQ) [Time frame: Up to 36 months after surgery]
- Overall survival (OS) [Time frame: Up to 36 months after surgery]
Eligibility criteria
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:
- 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
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 setting
- Participation in another clinical study with an treatment intervention during the course of this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 7 centers
- Medical spectrum Twente — Enschede
- Amsterdam University Medical Center — Amsterdam
- The Netherlands Cancer Institute — Amsterdam
- Amphia — Breda
- UMCG — Groningen
- Maastricht University Medical Center — Maastricht
- ErasmusMC — Rotterdam
Identifiers
NCT: NCT06931769 · M24TAO