NCT02701348

Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NHS Tayside · Other Government
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.

Detailed description

Background Endocrine resistance is a significant problem in the management of breast cancer, with increasing evidence that the tumour microenvironment is influential on tumour growth and disease resistance. The neoadjuvant setting provides an excellent opportunity to observe tumour response to treatment in vivo, allowing development of methods for monitoring and predicting response to treatment. Aims To assess potential radiological and biological tumoural and peri-tumoural biomarkers in patients before and during neoadjuvant endocrine treatment. Our hypothesis is that there will be less response in women with abnormal peri-tumoural stroma, and that tumours with high monocarboxyl transporter (MCT4) and loss of caveolin-1 in stroma are resistant to endocrine treatment. Techniques and Methodology Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, US including SWE, and MRI. Core biopsies will be taken at diagnosis and at surgery from tumour and peri-tumoural stroma, and assessed for biomarkers lysyl oxidase (LOX), fibronectin, collagen, proliferation, MCT4 and caveolin-1. All data will be correlated to peri-tumoural abnormalities on MRI and SWE. Impact on breast cancer research This study will provide information on the ability of SWE and MRI to predict and detect endocrine resistance, correlated with biological markers that are associated with endocrine resistance. Identifying resistant tumours can prevent unnecessary treatment and reduce risks of recurrence as alternative or additional therapies can be utilised.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Shearwave elastography	Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, ultrasound (US) including shearwave elastography (SWE). These will be performed at 3 monthly intervals until surgical intervention is considered feasible.
DRUG	Letrozole	Patients will be receiving neoadjuvant letrozole as standard therapy for breast cancer
PROCEDURE	Breast core biopsy	Core biopsies will be taken at diagnosis, and at the time of surgery to allow biological assessment of changes in tumour
OTHER	Magnetic Resonance Imaging	Breast MRI scans will be performed at time of diagnosis and prior to surgery to allow comparison of MRI change and response to treatment

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-12-24
• Completion: 2020-12-24
• First posted: 2016-03-08
• Last updated: 2021-08-06

Locations

1 site across 1 country: United Kingdom