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

The Netherlands Cancer Institute100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

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.

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)

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.

The HRQoL will be assessed through the following questionnaire: • Functional assessment of cancer therapy - endocrine symptoms (FACT-ES)

Time frame: Up to 36 months after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 36 months after surgery

Overall survival (OS)

Number of patients alive and dead

Time frame: Up to 36 months after surgery

Event-free survival

Number of patients with recurrence of disease

Time frame: 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.

Time frame: Up to 36 months after surgery

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

Overview

Conditions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts