Breast Care Current Research

The accuracy of two view digital x-ray mammography (2DDM) in breast cancer screening is limited because of superimposition of normal breast structures onto a two dimensional image. Mammography signs of breast cancer may be obscured, particularly in women with dense glandular breast tissue, resulting in delay in diagnosis of cancer. Interval cancer data shows that up to 4000 women per annum (2.88 per 1000 screened) are diagnosed with breast cancer in the interval between screens. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to unnecessary recall for further diagnostic tests.

Digital Breast Tomosynthesis (DBT) is an x-ray mammography technique which involves acquiring multiple low dose projection images over a limited angular range (less than 50 degrees). These projection images are reconstructed into a set of images consisting of parallel planes, typically 1mm apart throughout the breast, and provide three dimensional information to the film reader. A synthetic 2D mammogram (S 2D) has been developed using the data from the reconstructed DBT images.

Studies of DBT + 2DDM in screening have shown increased invasive cancer detection rates and lower false positive recall rates.There may be increased costs related to the technology and reading times.

The aim of this trial is to measure the impact and cost-effectiveness of DBT + 2DDM or S 2D in routine screening compared to standard 2DDM.

100,000 women will be recruited using NHS screening sites with DBT mammography equipment. At each site, through a clinic randomisation process, half the trial participants will undergo standard 2DDM (the control group) and half will undergo 2DDM + DBT (the intervention group). All cases will be double read - in the intervention group, one read will be DBT + 2DDM, and one read will be DBT + S 2D. Arbitration or consensus will be used for reader 1/2 discordance.

Project Details
Principal Investigator: Dr Alexandra Valencia
Planned End Date: 27/02/2024
Local Ref: 4441

Open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer – a phase III randomised multi-centre trial

The SMALL study is a research study which will help experts learn whether some women with small breast cancers, which are at low risk of spreading can be safely treated by removal of the cancer using a biopsy needle (under a local anaesthetic) instead of an operation.

The SMALL study will compare open surgery with a minimally invasive technique called vacuum-assisted excision (VAE) for the treatment of small breast cancers found at breast screening. Such small breast cancers have usually been treated with open surgery. The 2012 UK Breast Screening Review showed that breast screening does save lives, but that many women may be having more treatment than is necessary for their breast cancer.  Also, experts do not currently know how open surgery compares with other safe and effective methods to remove small breast cancers. We want to find out what the best treatment is for women like you, so that in future we can only operate on those women who really require surgery. We aim to do this by comparing open surgery with VAE. VAE is widely used in the Breast Screening Programme and has been successfully used instead of an operation to removal small benign tumours in the breast. Based on this, in the SMALL study we would like to find out if VAE (which involves the use of a biopsy needle to remove the cancer) will be as effective as an open operation.

A benefit from taking part in this study is that you will provide information that will help doctors change and improve the way breast cancer is treated in the future. Some women may be able to avoid unnecessary breast surgery in the future as a direct result of the knowledge gained from you taking part in this study.

Project Details
Principal Investigator: Miss Shelley Potter
Planned End Date: 30/11/2029
Local Ref: 4432

Breast cancer sometimes spreads to other areas of the body via the lymphatic system. The first place that cancer cells travel to is the armpit (also known as the axilla). Chemotherapy can be given as a first treatment to target these cells and reduce cancer in the armpit before surgery. This is called neoadjuvant chemotherapy.

After chemotherapy, further treatment to the armpit (either surgery or radiotherapy) is usually offered to everyone. This extra armpit treatment can cause troublesome side effects such as lymphoedema (arm swelling) and shoulder problems.

Sometimes neoadjuvant chemotherapy works so well that it removes all cancer cells in the armpit.

The ATNEC study is looking at whether, in these cases, further armpit treatment is needed.

Project Details
Principal Investigator: Miss Shelley Potter
Planned End Date: 30/12/2022
Local Ref: 4867

MARECA study has been designed to collect and analyse information about tumour characteristics and treatment details for the patient’s original and recurrent breast cancer. The study goal is to improve understanding of how this group of patients are currently being treated in the UK, as well as identify any variations in treatment. Following the patient’s long term treatment outcome will enable the research team to study tumour characteristics and treatment details in order to identify patient groups where treatment outcome was suboptimal. This will in turn enable future research and treatments to be targeted and tailored in order to improve future patient outcome. Cancer recurrence and long term outcomes of treatment were key themes that emerged from the National Cancer Research Institute’s ‘living with and beyond cancer research priorities’ project[69], who surveyed over 3500 patients, carers, and health and social care professionals.

Project Details

Principal Investigator: Miss Shelley Potter

Planned End Date: 31/12/2023

Local Ref (R&D no): 5128

This randomised controlled trial; patients are allocated by chance to one of two arms, which determines their treatment schedule. Hormone therapy is usually started after surgery. However, all participants in both trial arms will start hormone treatment (letrozole, anastrozole or exemestane) on joining the trial and prior to surgery. Therefore, they may have the opportunity to start treatment with hormone therapy before they normally would.

Participants in both arms have hormonal treatment for the same total length of time within the trial, but it is the timing of the surgery that differs. The type of surgery all participants will have will be determined by them and their clinical team as part of standard clinical care. Arm 1 will have surgery within 2-4 weeks (up to 8 weeks permitted for trial purposes) of joining the trial; arm 2 will receive surgery after 6 months (+/-1 month) of NET. Participants in arm 2 will receive an ultrasound (USS) scan at 3 months and 5 months to closely monitor their response to this hormone therapy prior to their surgery.

The overall aim is to evaluate whether 6 (+/-1) months of NET reduces surgical burden resulting in better HRQoL over 15 months and higher rates of breast conservation surgery (BCS) for post-menopausal women with ≥15mm (T1-3), strongly ER+, HER2- invasive breast cancer who do not require chemotherapy.

Project Details

Principal Investigator: Miss Shelley Potter

Planned End Date:28/02/2027

Local Ref (R&D no):5176

A prospective non-randomised, single-arm, multicentre, feasibility study for a proposed future randomised phase III clinical trial.

The primary objective is to determine whether patients with residual cancer can be identified by histological examination of multiple US-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer.

Project Details

Principal Investigator: Miss Alexandra Valencia

Planned End Date: 31/08/2027

Local Ref (R&D no): 5102