Prescribing Information LYNPARZA (olaparib) United Kingdom

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The importance of BRCA testing in HER2-negative breast cancer

Testing for BRCA mutations may offer a treatment opportunity to target a driver of breast cancer^1,2

The HR+/HER2-negative subtype is ~6x more common than TNBC and is likely to account for the majority of patients with gBRCAm breast cancer^3–7

~1 in 10 patients with HER2-negative breast cancer has a gBRCA mutation.^2–4,7–9

Of the patients with a gBRCA mutation:

ESMO guidelines recommend BRCA testing for both TNBC and HR+/HER2-negative breast cancers.¹⁰

A large 2019 population-based study conducted in the Netherlands assessed the 10-year recurrence rates of multiple breast cancer subtypes:¹¹

Of 8,062 patients involved in the study, 4,482 (56%) were HR+/HER2-negative and 986 (12%) had TNBC¹¹

Fear of recurrence is the most prevalent and disruptive source of distress for long-term breast cancer survivors.¹²

BRCA testing at diagnosis is critical to inform targeted treatment and surgical approach

Knowing your patients’ BRCA status early:

Early BRCA testing in HER2-negative breast cancer can identify patients with BRCA1/2 mutations who may be eligible for a targeted therapy, with the aim to improve patient outcomes.^1,21,22

BRCA testing is NHS-funded for your eligible patients with breast cancer²³

Click here to view the Blueteq eligibility criteria

Eligible patients with breast cancer should be tested at diagnosis for gBRCAm using the R208 test code or following (neo)adjuvant chemotherapy using the R444.1 test code to assess eligibility for LYNPARZA.²⁴

For patients with locally advanced or mBC, prior treatment with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting is required to be eligible for the R444.1 test code, unless these treatments were deemed unsuitable.²⁴

Please see the cited guidance documents for full recommendations.

If a gBRCAm is identified, consider prescribing LYNPARZA for your eligible patients.

Identify patients with early BC who are eligible for BRCA testing. You can find the eligibility criteria here

Explain the testing process to the patient and obtain patient's consent. Document the consent as a "record of discussion" in the patient's notes. You can find your local GLH here

Access our interactive pathway to deepen your understanding of the process of gBRCAm genomic testing in patients with HER2-negative breast cancer.

Click here

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BC, breast cancer; BRCA, breast cancer gene; DNA, deoxyribonucleic acid; eBC, early breast cancer; EDTA, ethylenediaminetetraacetic acid; gBRCAm, germline BRCA mutated; GLH, Genomic Laboratory Hub; HER2, human epidermal growth factor 2; HR+, hormone receptor positive; mBC, metastatic breast cancer; NHS, National Health Service; PARPi, poly (ADP-ribose) polymerase inhibitor; pN(0/1), pathologic node (0/1); TNBC, triple-negative breast cancer.

Waks AG and Winer EP. JAMA. 2019;321(3):288–300.
Winter C, et al. Ann Oncol. 2016;27(8):1532–1538.
Kurian AW, et al. J Clin Oncol. 2019;37(15):1305–1315.
Kurian AW, et al. J Clin Oncol. 2019;37(15):1305–1315. Supplementary appendix.
Cancer stat facts: Female breast cancer subtypes. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed March 2026.
American Cancer Society. Breast cancer facts & figures 2019–2020. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf. Accessed March 2026.
O’Shaughnessy J, et al. Breast Can Res. 2020;22(1):114.
Copson ER, et al. Lancet Oncol. 2018;19(2):169–180.
Kim H, et al. Medicina (Kaunas). 2020;56(10):514.
ESMO. Early Breast Cancer Guideline. Available at: https://interactiveguidelines.esmo.org/esmo-web-app/gl_toc/index.php?GL_id=114. Accessed March 2026.
van Maaren MC, et al. Int J Cancer. 2019;144(2):263–272.
Cohee AA, et al. Psychooncology. 2017;26(1):22–28.
BRCA Gene Mutations: Cancer risk and genetic testing. National Cancer Institute.  Available at: https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Accessed March 2026.
Chalasani P and Livingston R. Oncologist. 2013;18(8):909–916.
Kennedy RD, et al. J Natl Cancer Inst. 2004;96(22):1659–1668.
Sæther NH, et al. Hered Cancer Clin Pract. 2018;16(1):9.
Caramelo O, et al. Hered Cancer Clin Pract. 2019;17(1):11.
Consensus guideline on genetic testing for hereditary breast cancer. The American Society of Breast Surgeons.  Available at: https://www.breastsurgeons.org/docs/statements/Consensus-Guideline-on-Genetic-Testing-for-Hereditary-Breast-Cancer.pdf. Accessed March 2026.
Balmaña J, et al. Ann Oncol. 2011;22(suppl 6):vi31–vi34.
Arun B, et al. Br J Cancer. 2024;131(9):1400–1414.
Becourt S, et al. J Clin Oncol. 2018;36(1):e13522.
Baretta Z, et al. Medicine. 2016;95(1):e4975.
NHS. National Cancer Drugs Fund list. Available at: https://www.england.nhs.uk/publication/national-cancer-drugs-fund-list/. Accessed March 2026.
NHS England. National Genomic Test Directory. Available at: https://www.england.nhs.uk/publication/national-genomic-test-directories. Accessed March 2026.
NHS Scotland. Scottish Genomic Test Directories. Available at: https://www.genomics.nhs.scot/test-directories/. Accessed March 2026.

GB-71735 | March 2026

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The importance of BRCA testing in HER2-negative breast cancer

Testing for BRCA mutations may offer a treatment opportunity to target a driver of breast cancer1,2

The HR+/HER2-negative subtype is ~6x more common than TNBC and is likely to account for the majority of patients with gBRCAm breast cancer3–7

Of the patients with a gBRCA mutation:

ESMO guidelines recommend BRCA testing for both TNBC and HR+/HER2-negative breast cancers.10

While the risk of recurrence for patients with TNBC is initially higher, patients with HR+/HER2-negative breast cancer generally have a consistent recurrence risk11

BRCA testing at diagnosis is critical to inform targeted treatment and surgical approach

BRCA testing is NHS-funded for your eligible patients with breast cancer23

If a gBRCAm is identified, consider prescribing LYNPARZA for your eligible patients.

Scottish guidelines recommend BRCA testing at diagnosis according to specific eligibility criteria25

Finding your patients' BRCA status requires communication with your local GLH to send a sample for testing

Collecting liquid biopsies for gBRCAm testing involves the following steps to obtain a blood sample and send it to the appropriate location

Access our interactive pathway to deepen your understanding of the process of gBRCAm genomic testing in patients with HER2-negative breast cancer.

Click here

Sign up to our mailing list

Abbreviations and References

Testing for BRCA mutations may offer a treatment opportunity to target a driver of breast cancer^1,2

The HR+/HER2-negative subtype is ~6x more common than TNBC and is likely to account for the majority of patients with gBRCAm breast cancer^3–7

ESMO guidelines recommend BRCA testing for both TNBC and HR+/HER2-negative breast cancers.¹⁰

BRCA testing is NHS-funded for your eligible patients with breast cancer²³