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Breast CancerTAONCT06931769

TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer

An observational study of Breast Cancer, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
How many people
100 participants
Where
9 sitesNetherlands
Study dates
6 Nov 2025to 1 Jul 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with stage III, hormone receptor (HR)-negative HER2-negative, adenocarcinoma of the breast (TNBC).

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pien Debets, Study coordinator contact

0205129111

p.debets@nki.nl

Ingrid Mandjes, Clinical Projects Manager contact

9 sites in 1 country

Netherlands9 sites, 9 recruiting

  • Amsterdam University Medical Center

    Amsterdam

    Not yet recruiting

  • The Netherlands Cancer Institute

    Amsterdam

    Sabine Linn, Prof, +3125129111, s.linn@nki.nl

    Recruiting

  • Amphia

    Breda

    J B Heijns, MD, JHeijns@amphia.nl

    J B Heijns, MD

    Recruiting

  • Deventer ziekenhuis

    Deventer

    L W Kessels, MD, 310570535353, L.W.Kessels@dz.nl

    L W Kessels, MD

    Not yet recruiting

  • Medical spectrum Twente

    Enschede, Overijssel, 7500 KA

    M Wymenga, MD

    M Wymenga, MD

    Recruiting

  • UMCG

    Groningen, 9713 GZ

    J Nuver, MD

    J Nuver, MD

    Recruiting

  • Maastricht University Medical Center

    Maastricht

    V Tjan-Heijnen, MD, a.jager@erasmusmc.nl

    V Tjan-Heijnen, Prof. MD

    Recruiting

  • CWZ

    Nijmegen

    C MPW Mandigers, MD, 3124 3657657, c.mandigers@cwz.nl

    C MPW Mandigers, MD

    Not yet recruiting

  • ErasmusMC

    Rotterdam

    Agnes Jager, Prof. MD, a.jager@erasmusmc.nl

    Agnes Jager, Prof. MD

    Recruiting

Other trials in Netherlands

About this study

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.

Conditions
Breast Cancer
Keywords
Stage III, Triple Negative, Neo adjuvant treatment, Quality of Life
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 36 months after surgery

  2. 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)

    Measured: Up to 36 months after surgery

  3. 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)

    Measured: Up to 36 months after surgery

Secondary outcomes (14)

  1. 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.

    Measured: Up to 24 months after start treatment

  2. 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.

    Measured: Up to 36 months after surgery

  3. 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.

    Measured: Up to 36 months after surgery

  4. 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.

    Measured: Up to 36 months after surgery

  5. 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.

    Measured: Up to 36 months after surgery

  6. 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.

    Measured: Up to 36 months after surgery

  7. 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.

    Measured: Up to 36 months after surgery

  8. 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.

    Measured: Up to 36 months after surgery

  9. 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.

    Measured: Up to 36 months after surgery

  10. 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.

    Measured: Up to 36 months after surgery

  11. 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.

    Measured: Up to 36 months after surgery

  12. Overall survival (OS)

    Number of patients alive and dead

    Measured: Up to 36 months after surgery

  13. Event-free survival

    Number of patients with recurrence of disease

    Measured: Up to 36 months after surgery

  14. 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.

    Measured: Up to 36 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start6 Nov 2025
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931769
Sponsor's protocol ID
M24TAO
Acronym
TAO
Status last verified
Oct 2026
First submitted
28 Oct 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pien Debets, Study coordinator (0205129111, p.debets@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Up to 36 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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