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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Breast Cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 02/06/2021:
1. Female aged ≥47 years old with screen-detected breast cancer
2. ≤15 mm maximum tumour diameter on mammogram and ultrasound
3. No associated malignant microcalcification outwith the mass lesion (calcification within the lesion is permitted)
4. Unifocal disease
5. Grade 1 disease on diagnostic core biopsy
6. ER strongly positive (Allred score of 7 or 8, or equivalent, e.g. at least moderate positivity in >66% of tumour cell nuclei)
7. PR strongly positive (Allred score of 7 or 8, or equivalent, e.g. at least moderate positivity in >66% of tumour cell nuclei)
8. HER2 negative (0 or 1+ by immunohistochemistry, or 2+ and negative by in situ hybridisation techniques (FISH or DISH)
9. Normal axillary ultrasound axillary, or equivocal ultrasound with benign fine needle aspiration cytology (FNAC) or core biopsy (CB)
10. Willing to be randomised
11. Able to provide written informed consent
12. Willing and able to undergo standard surgical treatment
13. Willing and able to undergo radiotherapy
14. Willing and able to take standard endocrine therapy
15. No previous diagnosis of ipsilateral breast cancer or DCIS (contralateral DCIS or invasive disease permitted if surgically treate
You may not be able to take part if:
Current exclusion criteria as of 02/06/2021:
1. Associated malignant microcalcification outwith the lesion2. Bilateral breast cancer3. Invasive lobular cancer4. Grade 2 or grade 3 on core biopsy assessment5. Not strongly ER or PR positive (Allred score of <7, or equivalent, e.g. <66% positivity of tumour cell nuclei) or HER2 positive tumour6. Unable to provide informed consent7. Any serious and/or unstable pre-existing medical, psychiatric or other condition that would prevent compliance with the trial or consent process8. Unfit or unwilling to undergo standard surgical treatment9. Contra-indications to standard adjuvant therapies (radiotherapy, endocrine therapy)10. Previous ipsilateral invasive breast cancer or DCIS11. Other invasive malignancy unless:- Disease free for 5 years, or-Previous basal cell carcinoma, cervical carcinoma in-situ, superficial bladder tumour12. High-risk group for developing breast cancer (as defined by NICE guidance)
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Previous exclusion criteria:
1. Lesions with associated mammographic microcalcification outwith the lesion2. Bilateral breast cancer3. Invasive lobular cancer4. Grade 2 or grade 3 on core biopsy assessment5. ER or PR negative or HER2 positive tumour6. Unable to provide informed consent7. Any serious and/or unstable pre-existing medical, psychiatric or other condition that would prevent compliance with the trial or consent process8. Unfit or unwilling to undergo standard surgical treatment9. Contra-indications to standard adjuvant therapies (radiotherapy, endocrine therapy)10. Previous ipsilateral invasive breast cancer or DCIS11. Other invasive malignancy treated within the last 5 years12. High-risk group for developing breast cancer (as defined by NICE guidance)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Dr
Jessica
Foster
+44 (0)121 414 9021
small@trials.bham.ac.uk
The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/42/32.
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