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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Pien Debets, Study coordinator; Phone Number: 0205129111; Email: p.debets@nki.nl
• Study Contact Backup: Name: Ingrid Mandjes, Clinical Projects Manager

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • Amsterdam University Medical Center
  • Amsterdam, Netherlands
    • Recruiting
    • the Netherlands Cancer Institute
    • Contact: Sabine Linn, Prof; Phone Number: +3125129111; Email: s.linn@nki.nl
  • Breda, Netherlands
    • Not yet recruiting
    • Amphia
    • Contact: J B Heijns, MD; Email: JHeijns@amphia.nl
    • Principal Investigator: J B Heijns, MD
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • UMCG
    • Contact: J Nuver, MD
    • Principal Investigator: J Nuver, MD
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University Medical Center
    • Contact: V Tjan-Heijnen, MD; Email: a.jager@erasmusmc.nl
    • Principal Investigator: V Tjan-Heijnen, Prof. MD
  • Rotterdam, Netherlands
    • Recruiting
    • ErasmusMC
    • Contact: Agnes Jager, Prof. MD; Email: a.jager@erasmusmc.nl
    • Principal Investigator: Agnes Jager, Prof. MD
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7500 KA
      • Recruiting
      • Medical spectrum Twente
      • Contact: M Wymenga, MD
      • Principal Investigator: M Wymenga, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	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.	The HRQoL will be assessed through the following questionnaire: • Functional assessment of cancer therapy - endocrine symptoms (FACT-ES)	Up to 36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months after start treatment
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
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.	Up to 36 months after surgery
Overall survival (OS)	Number of patients alive and dead	Up to 36 months after surgery
Event-free survival	Number of patients with recurrence of disease	Up to 36 months after surgery
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.	Up to 36 months after surgery

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Dutch Cancer Society

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Triple Negative; Stage III; Neo adjuvant treatment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: M24TAO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No