Test for gBRCA mutations* in patients with HER2-negative BC to help determine eligibility for LYNPARZA1

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REVIEW IMPORTANT SAFETY INFORMATION BELOW

*Select patients based on an FDA-approved companion diagnostic for LYNPARZA.1

WHO

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The majority of patients with gBRCAm, HER2-negative BC have HR-positive disease2,3,5

1 in 10 patients with HER2-negative BC has a gBRCA mutation 1 in 10 patients with HER2-negative BC has a gBRCA mutation

~1 in 10 patients with HER2-negative BC has a gBRCAm4-10

Among patients with gBRCA mutations and HER2-negative breast cancer, more patients have HR-positive disease5†:

~60%

HR-positive, HER2-negative

~40%

TNBC

  • The prevalence of BRCAm is higher among patients with TNBC (~15%) compared to patients with HR-positive, HER2-negative disease (~5%)11†
  • However, HR-positive, HER2-negative disease is ~6x more common than TNBC2,3

†From a systematic review, summarizing international BRCA1/2 mutation prevalence in breast cancer. In 4 large, unselected studies in TNBC, gBRCAm prevalence varied from 9.3% (Australia) to 15.4% (US). gBRCAm prevalence in 1 large, unselected HR-positive, HER2-negative early breast cancer study was 5% (US).11

WHEN

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Test for gBRCA mutations at the earliest opportunity in both the adjuvant and metastatic settings

Test for gBRCA Mutations in the Adjuvant Setting

IN THE ADJUVANT SETTING

Not an actual patient.

Test patients with HER2-negative eBC at diagnosis to help inform surgical and post-surgical treatment decisions.1,12

Test for gBRCA Mutations in the Metastatic Setting

IN THE METASTATIC SETTING

Not an actual patient.

If not previously tested, test all patients with HER2-negative mBC at initial metastatic workup.1

WHY

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Identifying gBRCA mutations at diagnosis may help determine the earliest eligibility for LYNPARZA1

Testing may also:

  • Inform screening for ovarian and other BRCA mutation-associated cancers12,13
  • Provide information on genetic/familial risks12

Incorporate a multidisciplinary approach to gBRCAm testing

  • The National Comprehensive Cancer Network® (NCCN®) recommends that a healthcare professional with experience in cancer genetics be involved in counseling at all steps of the process for genetic testing, including pre-test counseling prior to ordering testing and post-test counseling when results are disclosed14
  • Identify gBRCA mutations early to help inform surgical and post-surgical treatment decisions12
  • Test for gBRCA mutations based on an FDA-approved companion diagnostic1

Learn more about the efficacy of LYNPARZA

In select patients with HER2-negative breast cancer

gBRCAm testing is recommended by leading medical authorities14-16

NCCN Guidelines® Recommend

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend germline BRCA testing at any age for certain patients with a personal history of breast cancer to aid treatment decisions with PARP inhibitors, including olaparib

Treatment indications at any age:

  • To aid in systemic treatment decisions using PARP inhibitors for breast cancer in metastatic setting
  • To aid in adjuvant treatment decisions with olaparib for high-risk,* HER2-negative breast cancer

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

*High-risk disease in patients with TNBC is defined as either 1) treated with adjuvant chemotherapy and with axillary node-positive disease or an invasive breast tumor ≥2 cm on pathology analysis or 2) treated with neoadjuvant chemotherapy and with residual invasive breast cancer in the breast or resected lymph nodes. High-risk disease in patients with HR-positive, HER2-negative disease is defined as either 1) treated with adjuvant chemotherapy and with ≥4 positive pathologically confirmed lymph nodes or 2) treated with neoadjuvant chemotherapy which did not have a complete pathologic response and with a CPS&EG score of ≥3.


ASCO-SSO® Guidelines Recommend†

gBRCA1/2 mutation testing should be offered to:

  • All patients newly diagnosed with breast cancer with stage I-III or de novo stage IV/metastatic disease who are 65 years or younger at diagnosis should be offered BRCA1/2 testing (Type: Formal Consensus; Agreement: 87.50%).
  • All patients newly diagnosed with breast cancer with stage I-III or de novo stage IV/metastatic disease who are older than age 65 should be offered BRCA1/2 testing if:
    • they are candidates for poly (ADP-ribose) polymerase (PARP) inhibitor therapy for early-stage or metastatic disease,
    • they have triple-negative breast cancer, their personal or family history suggests the possibility of a pathogenic variant,
    • they were assigned male sex at birth, they are of Ashkenazi Jewish ancestry, or are members of a population with an increased prevalence of founder mutations (Type: Formal Consensus; Agreement: 92.50%).

ASBrS® Guidelines Recommend

Genetic testing, including gBRCA1/2 mutation testing, should be made available to all patients with a personal history of breast cancer to help:

  • Inform treatment decisions, including surgery, potential radiotherapy, and systemic therapy
  • Assess hereditary risk

†The information in this brochure is not intended to substitute for the independent professional judgment of the treating provider, as the information does not account for individual variation among patients.

Explore related content:

OlympiAEfficacy

Review the efficacy data, including 6-year exploratory analysis, for patients with gBRCAm, HER2-negative, high-risk eBC. The OlympiA trial enrolled patients with HR+ or triple-negative breast cancer.

Explore the OlympiA data

OlympiASafety

See the most common adverse reactions and lab abnormalities among patients treated in the OlympiA trial.

Review the safety data

LYNPARZA eBC Data Brochure

Download a resource for complete summaries of efficacy and safety data from the OlympiA trial, a clinical trial for gBRCAm, HER2-negative early BC, including exploratory 6-year follow-up data.

Download

ASBrS=American Society of Breast Surgeons; ASCO-SSO=American Society of Clinical Oncology–Society of Surgical Oncology; BC=breast cancer; BRCAm=BRCA-mutated; CPS&EG=pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status, and histologic grade; eBC=early breast cancer; gBRCA=germline BRCA; gBRCAm=germline BRCA-mutated; HER2=human epidermal growth factor receptor; HR=hormone receptor; HRR=homologous recombination repair; IDFS=invasive disease-free survival; mBC=metastatic breast cancer; NCCN=National Comprehensive Cancer Network® (NCCN®); PARP=poly (ADP-ribose) polymerase; TNBC=triple-negative breast cancer.

References: 1. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Hu C, Polley EC, Yadav S, et al. The contribution of germline predisposition gene mutations to clinical subtypes of invasive breast cancer from a clinical genetic testing cohort. J Natl Cancer Inst. 2020;112(12):1231-1241. 3. Cancer Stat Facts: female breast cancer subtypes. National Cancer Institute. Accessed December 22, 2025. https://seer.cancer.gov/statfacts/html/breast-subtypes.html 4. Kurian AW, Ward KC, Howlader N, et al. Genetic testing and results in a population-based cohort of breast cancer patients and ovarian cancer patients. J Clin Oncol. 2019;37(15):1305-1315. 5. Kurian AW, Ward KC, Howlader N, et al. Genetic testing and results in a population-based cohort of breast cancer patients and ovarian cancer patients. Supplementary material. Table S3: genetic test results by breast cancer biomarker subtypes among breast cancer patients. J Clin Oncol. 2019;37(15):1305-1315. 6. Winter C, Nilsson MP, Olsson E, et al. Targeted sequencing of BRCA1 and BRCA2 across a large unselected breast cancer cohort suggests that one-third of mutations are somatic. Supplementary material. Table S4: BRCA status and clinical characteristics. Ann Oncol. 2016;27(8):1532-1538. 7. Copson ER, Maishman TC, Tapper WJ, et al. Germline BRCA mutation and outcome in young-onset breast cancer (POSH): a prospective cohort study. Lancet Oncol. 2018;19(2):169-180. 8. Kim H, Choi DH, Park W. Germline BRCA mutation and clinical outcomes in breast cancer patients focusing on survival and failure patterns: a long-term follow-up study of Koreans. Medicina (Kaunas). 2020;56(10):514. 9. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-1468.
10. O’Shaughnessy J, Brezden-Masley C, Cazzaniga M, et al. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res. 2020;22(1):114. 11. Armstrong N, Ryder S, Forbes C, Ross J, Quek RG. A systematic review of the international prevalence of BRCA mutation in breast cancer. Clin Epidemiol. 2019:11:543-561. 12. Manahan ER, Kuerer HM, Sebastian M, et al. Consensus Guidelines on Genetic Testing for Hereditary Breast Cancer from the American Society of Breast Surgeons. Ann Surg Oncol. 2019;26(10):3025-3031. 13. BRCA gene mutations: cancer risk and genetic testing. National Cancer Institute. Updated July 19, 2024. Accessed December 22, 2025. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet 14. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed February 19, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org 15. Bedrosian I, Somerfield MR, Achatz MI, et al. Germline testing in patients with breast cancer: ASCO–Society of Surgical Oncology guideline. J Clin Oncol. 2024;42(5):584-604. 16. Consensus Guideline on Genetic Testing for Hereditary Breast Cancer. The American Society of Breast Surgeons. Published February 10, 2019. Accessed August 26, 2025. https://www.breastsurgeons.org/docs/statements/Consensus-Guideline-on-Genetic-Testing-for-Hereditary-Breast-Cancer.pdf