The Epidemiology of breast cancer subtypes in England as defined by hormone receptor status and HER2 status (ODR1516_099)

University of Oxford requires access to NHS England data for the purpose of the following research project: The Epidemiology of breast cancer subtypes in England as defined by hormone receptor status and HER2 status.

The following is a summary of the aims of the research project provided by University of Oxford:

Primary objective:

To describe the epidemiology in England of four main breast cancer subtypes, (Luminal A, Luminal B, Her2 enriched, Triple negative) as defined by oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor 2 (HER2) expression, in relation to age and ethnicity of women with breast cancer, and other patient and tumour characteristics.

Secondary objective:

To describe the subsequent treatment patterns of four main breast cancer subtypes, as defined by oestrogen (ER) receptor, progesterone receptor (PR) and human epidermal growth factor 2 (HER2) expression, and other molecular subtyping tools such as OncotypeDX, and impact on subsequent survival of women with breast cancer and to link these treatment outcomes to patient experience.

The following NHS England Data will be accessed:

• NDRS Linked Cancer Registration

• NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

• NDRS Radiotherapy Dataset (RTDS)

• NDRS Linked Cancer Waiting Times (Treatment Data) (CWT)

The level of the Data will be pseudonymised.

The Data will be minimised as follows:

• Limited to patient diagnosed between 01/01/2006 – latest available

• Limited to the following geographic areas: England

• Limited to female patients

• Limited to patients above the age of 24 years at diagnosis

• Limited to conditions relevant to the study identified by specific ICD or OPCS codes;

o ICD10 – C50x or D05x

o OPCS4 - OPCS4 events will be limited to codes BCS (B28, B281, B282, B283, B285, B286, B287, B288, B289 MARGIN: B284 Mastectomy (B27, B271, B272, B27, B274, B275, B276, B278, B279) SLNB: (O142, T87, T873, T878, T879, T91, T911, T912, T919, T928) Sampling: (T86, T862, T868, T869) Axillary Dissection (Z613, T852, T858, T859) Breast Reconstruction: (B29, B291, B292, B293, B294, B295, B298, B299, B30, B301, B302, B303, B304, B308, B31, B311, B312, B313, B314, B318, B319, Biopsy of breast: B32, B321, B322, B323, B328, B329 Incision of breast: (B33, B331, B332, B333, B338, B339) Operations on duct of breast: (B34, B341, B342, B343, B344, B345, B348, B349) Nipple operations: (B35, B351, B352, B353, B354, B355, B356, B358, B359) Reconstruction of nipple and areola: (B36, B361, B362, B363, B364, B368, B369) Other breast procedure: (B37, B371, B372, B374, B375, B378, B379) Reconstruction of breast using flap of skin of buttock: (B38, B381, B382) Reconstruction of breast using abdominal flap: (B39, B391, B392, B393 B398, B399) Destruction of lesion of breast: (B40, B409)

University of Oxford is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding is provided by Cancer Research UK. The funding is specifically for the study described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

In line with the national data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and section 251(11) of the National Health Service Act 2006.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NDRS Linked Cancer Registration, NDRS SACT, NDRS RTDS and NDRS CWT datasets to University of Oxford. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Oxford.

The Data will be accessed onsite at the premises of the University of Oxford only.

The Data will not leave England/Wales at any time.

Access is restricted to substantive employees of the University of Oxford who have authorisation from the Principal Investigator .

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data outside of this agreement.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts from the University of Oxford Cancer Epidemiology Unit (CEU) will analyse the Data for the purposes described above.

Findings will be disseminated in general cancer journals such as the British Journal of Cancer – likely date for publication would be anticipated to be 2026, with preliminary findings likely presented at relevant scientific meetings such as the UKIBCS in 2024, and the Association of Breast Surgery annual conferences.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Scientific meetings

Future anticipated work, including the cancer registry data during 2023-2026, will include updating the analyses on tumour characteristics and ethnicity, to incorporate molecular subtypes as and when the numbers of cancers registered are sufficient in the subgroups of interest.

Other planned analyses include the associations of tumour characteristics, by age, ethnicity and route to diagnosis.

This research aligns with the NHS Quality agenda tackling inequalities. The study is wholly aligned to the NHS Cancer Plan which states that the key ambitions will be delivered in a way that reduces variations and inequalities.

This research is focused on describing the associations of breast cancer and ethnicity, the results of will identify gaps in care, and suggest inform the policies needed to address them.

As breast cancer is not a single disease, it is important to understand the patient and tumour factors that influence response to treatment. This will further support the NHS to make decisions about patient-tailored treatment strategies.

As breast cancer is not a single disease, it is important to understand the patient and tumour factors that influence response to treatment. This will further support the NHS to make decisions about patient-tailored treatment strategies.

The following peer reviewed publications have arisen from these data:

• Gathani T, Reeves GK, Broggio J, Barnes I:

Ethnicity and the tumour characteristics of invasive breast cancer in over 116 500 women in England

Br J Cancer 2021: doi: 10.1038/s41416-021-01409-7

• Gathani T, Chuiri K, Broggio J, Reeves G, Barnes I:

Ethnicity and the surgical management of breast cancer in over 164 000 women in England

Br J Surgery 2020: https://doi.org/10.1002/bjs.11865

• Gathani T, Chaudhury A, Chagla L, Chopra S, Copson E, Purushotham A, Raghavan V, Cuttress R:

Ethnicity and breast cancer in the UK: where are we now?

Eur J Surg Oncology 2021: https://doi.org/10.1016/j.ejso.2021.08.025

These papers formed the basis of a successful grant application to the Prevention and Population Research Committee at Cancer Research UK to investigate further the associations of ethnicity and breast cancer.

Update 08 January 2024:

This research project is exploring the distribution of four breast cancer subtypes in England by certain patient characteristics and to identify any potential differences, not only in the treatment of these cancers but also in the experience of cancer treatment that these patients receive. By using pseudonymised data from the National Cancer Registration and Analysis Service, the researchers aim to provide detailed, reliable and nationally representative information about the clinical outcomes of different breast cancer subtypes for women in England, adjusted for age and region and other patient and tumour factors.

Primary aim: To describe the epidemiology in England of four main breast cancer subtypes, (Luminal A, Luminal B, Her2 enriched, Triple negative) as defined by oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor 2 (HER2) expression, in relation to age and ethnicity of women with breast cancer, and other patient and tumour characteristics.

Secondary aim: To describe the subsequent treatment patterns of four main breast cancer subtypes, as defined by oestrogen (ER) receptor, progesterone receptor (PR) and human epidermal growth factor 2 (HER2) expression, and other molecular subtyping tools such as OncotypeDX, and impact on subsequent survival of women with breast cancer and to link these treatment outcomes to patient experience.

The following peer reviewed publications have arisen from these data:

• Gathani T, Reeves GK, Broggio J, Barnes I: Ethnicity and the tumour characteristics of invasive breast cancer in over 116 500 women in England Br J Cancer 2021: doi: 10.1038/s41416-021-01409-7

• Gathani T, Chuiri K, Broggio J, Reeves G, Barnes I: Ethnicity and the surgical management of breast cancer in over 164 000 women in England Br J Surgery 2020: https://doi.org/10.1002/bjs.11865

• Gathani T, Chaudhury A, Chagla L, Chopra S, Copson E, Purushotham A, Raghavan V, Cuttress R: Ethnicity and breast cancer in the UK: where are we now? Eur J Surg Oncology 2021: https://doi.org/10.1016/j.ejso.2021.08.025

These papers formed the basis of a successful grant application to the Prevention and Population Research Committee at Cancer Research UK to investigate further the associations of ethnicity and breast cancer. Future anticipated work, including the cancer registry data during 2023-2026, will include updating the analyses on tumour characteristics and ethnicity, to incorporate molecular subtypes as and when the numbers of cancers registered are sufficient in the subgroups of interest. Other planned analyses include the associations of tumour characteristics, by age, ethnicity and route to diagnosis. Findings will be disseminated in general cancer journals such as the British Journal of Cancer – likely date for publication would be anticipated to be 2026, with preliminary findings likely presented at relevant scientific meetings such as the UKIBCS in 2024, and the Association of Breast Surgery annual conferences.