Clinical trial NCT06931769: TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Official title: TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: Stage III
Triple Negative
Neo adjuvant treatment
Quality of Life
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2025-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with stage III, hormone receptor (HR)-negative HER2-negative, adenocarcinoma of the breast (TNBC).

Brief summary: 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 seven 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.


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.

Primary outcomes:
measure: 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.
timeFrame: Up to 36 months after surgery
measure: 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.
timeFrame: Up to 36 months after surgery
measure: 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.
timeFrame: Up to 36 months after surgery
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 24 months after start treatment
measure: Cognitive functioning - Questionnaire
timeFrame: Up to 36 months after surgery
measure: Cognitive functioning - ASC (Amsterdam Cognition Scan)
timeFrame: Up to 36 months after surgery
measure: Oral health related quality of life (QoL) - EORTC-QLQ-OH15
timeFrame: Up to 36 months after surgery
measure: Oral health related quality of life (QoL) - Xerostomia Inventory
timeFrame: Up to 36 months after surgery
measure: Oral health related quality of life (QoL) - Oral Impact on Daily Performance index
timeFrame: Up to 36 months after surgery
measure: Oral health related quality of life (QoL) - oral self-care questionnaire
timeFrame: Up to 36 months after surgery
measure: Resource use - Dutch hospital data (DHD)
timeFrame: Up to 36 months after surgery
measure: Costs - Dutch hospital data (DHD)
timeFrame: Up to 36 months after surgery
measure: Resource use - iMTA Medical Consumption Questionnaire (iMCQ)
timeFrame: Up to 36 months after surgery
measure: Resource use - iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: Up to 36 months after surgery
measure: Overall survival (OS)
timeFrame: Up to 36 months after surgery
measure: Event-free survival
timeFrame: Up to 36 months after surgery
measure: ctDNA dynamics
timeFrame: Up to 36 months after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
Study officials:
References: