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

NCT06931769 | Recruiting

• 1 other identifier: M24TAO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

Stage III; Triple Negative; Neo adjuvant treatment; Quality of Life

Outcome Measures

Primary Outcomes (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 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 Outcomes (14)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 24 months after start treatment

• Cognitive functioning - Questionnaire

  Up to 36 months after surgery

• Cognitive functioning - ASC (Amsterdam Cognition Scan)

  Up to 36 months after surgery

• Oral health related quality of life (QoL) - EORTC-QLQ-OH15

  Up to 36 months after surgery

• Oral health related quality of life (QoL) - Xerostomia Inventory

  Up to 36 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Cancer Society: collaborator

Study Sites (6)

Medical spectrum Twente

Enschede, Overijssel, 7500 KA, Netherlands

RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

The Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

UMCG

Groningen, 9713 GZ, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

ErasmusMC

Rotterdam, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for ctDNA (cirulating tumor)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Pien Debets, Study coordinator

CONTACT

0205129111; p.debets@nki.nl

Ingrid Mandjes, Clinical Projects Manager

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: April 17, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

NL (6)