How Can We Continue Improving Survival Rates for Certain gBRCAm Breast Cancer Patients? A Q&A with AstraZeneca’s Carlos Doti

Despite notable advances in breast cancer therapies, there is a critical need to improve outcomes for those with BRCA1/BRCA2 gene mutations, which account for up to 10% of all breast cancer cases.1 These patients often face a particularly aggressive form of the disease and have an elevated risk of secondary cancers, making their cancer more challenging to treat.2

We spoke with Carlos Doti, MD, Head of Medical Affairs for US Oncology at AstraZeneca, about how poly (ADP-ribose) polymerase (PARP) inhibitors such as LYNPARZA® (olaparib) are helping to meet these patients’ needs, as well as sharing specific insights into clinical trial data supporting the regimen.

Q1: Can you talk about BRCA genes and their relationship to treatment with PARP inhibitors?

BRCA1 and BRCA2 are genes that produce proteins responsible for repairing damaged DNA and helping to maintain the genetic stability of cells.1 When either gene is mutated, cells may become unstable, making tumor growth more likely and significantly increasing the risk of cancer.1 These genetic alterations can also make the cells more sensitive to PARP inhibitors, which prevent the repair of DNA in cancerous cells and cause them to die.3

LYNPARZA is a targeted therapy first approved by the FDA as a treatment for recurrent ovarian cancer, with multiple indications to follow across ovarian, pancreatic, and prostate cancers.4,5 It was approved for gBRCAm, HER2-negative metastatic breast cancer in 2018 and for adjuvant treatment of gBRCAm, HER2-negative, high-risk early breast cancer in 2022.5,6 In in-vitro activity studies, LYNPARZA demonstrated efficacy to block DNA damage response (DDR) in cells and tumors with a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2.5,6

Q2: How has LYNPARZA impacted the treatment landscape of gBRCAm breast cancer?

PARP inhibitors have changed the treatment of gBRCAm breast cancer with improved progression-free (PFS), invasive disease-free (IDFS) and overall survival (OS).7,8

Patients with BRCA mutations face a difficult diagnosis, including the potential for more aggressive disease and a higher risk of recurrence, often at a younger age. In the past, these patients’ options were limited to chemotherapy and endocrine therapy. Despite these treatments, relapse and death have persisted among this patient population.8 LYNPARZA provides a targeted treatment for certain HER2-negative patients with a gBRCA mutation and either early or metastatic breast cancer.5

Treatment with LYNPARZA has shown promising clinical results in early breast cancer. The OlympiA phase III clinical study of patients with gBRCAm, HER2-negative, high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy signified the first time a PARP inhibitor delivered clinically meaningful improvements in the primary endpoint of IDFS [HR=0.58 (95% CI: 0.46-0.74); P<0.0001] and the secondary endpoint of overall survival in eBC.5 LYNPARZA compared to placebo was found to reduce the relative risk of death by 32% at a median follow-up of 3.5 years [75 events in the LYNPARZA group vs 109 events in the placebo group; HR 0.68 (95% CI 0.50, 0.91); P=0.0091]. In late 2024, an exploratory analysis of the OlympiA trial with a median follow-up of 6 years supported the IDFS and OS outcomes from the primary analysis.9

Approximately 20-30% of patients diagnosed with early breast cancer will progress to the metastatic stage of the disease, for which there is no cure.10,11 OlympiAD – the first positive Phase III trial to demonstrate improved progression-free survival with a PARP inhibitor in BRCA-mutated HER2-negative mBC – showed LYNPARZA reduced relative risk of disease worsening or death by 42% [median progression-free survival 7.0 months with LYNPARZA vs 4.2 months with physician's choice of chemotherapy; HR 0.58 (95% CI 0.43, 0.80); P=0.0009].5,12

Q3: How should healthcare providers manage LYNPARZA treatment with their patients?

In both the OlympiA and OlympiAD trials, adverse reactions were usually managed by dose interruption or dose reduction, rather than by discontinuation. If a patient experiences an adverse reaction, learn more about guideline-based AR management strategies.

This is not all the information related to managing LYNPARZA's side effects and dosing. Please see the link to the complete Prescribing Information below for more information.

Please find complete Important Safety Information below or click here.

Q4: What’s the role of genetic testing when it comes to treating gBRCAm breast cancer patients?

Genetic testing is the first important step in identifying breast cancer patients who have a gBRCA mutation, which could expand treatment options for those diagnosed with early or metastatic disease. Identifying gBRCA mutations at diagnosis may also provide information on genetic and familial risks, helping to prompt testing for the hereditary mutation in other family members.1

ASCO and the Society of Surgical Oncology issued joint guidelines* in January 2024 noting BRCA1/BRCA2 mutation testing should be offered to all newly diagnosed breast cancer patients 65 and younger, as well as certain patients older than 65 based on personal or family history of cancer, patients assigned male at birth, especially those diagnosed with triple-negative breast cancer, as well as those with certain ancestries.13

*These are not comprehensive guideline recommendations.

These guidelines support expanded access to genetic testing and help us reach more patients. It’s our hope that this will encourage more patients, especially those diagnosed with hormone receptor-positive (HR+) breast cancer for whom testing rates lag compared to patients with triple-negative breast cancer, to get testing and guidance for their best treatment options, but education is imperative.

The BRACAnalysis CDx® can identify breast cancer patients who may be eligible for treatment with targeted therapies like LYNPARZA.

Q5: What should oncologists understand to help increase genetic testing rates in HR+ and triple negative breast cancers?

There are several factors that impact genetic testing rates, and BRCA testing is not as widespread as it needs to be, especially for patients with HR+ breast cancer.14-16

In my experience, knowledge is power. Knowing your BRCA status and having the opportunity to receive certain targeted treatment options should not just be for some – it should be for all eligible patients. We get there through education and access.

Talk to your patients about genetic testing and help them understand how it could impact them. Make sure anyone that can and should get tested does get tested.

For more information about the data and potential treatment options for breast cancer, please visit lynparzahcp.com.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients (26/2219) with various BRCAm, gBRCAm, HRR gene-mutated or HRD-positive cancers who received LYNPARZA in clinical studies as a single agent or as part of a combination regimen, consistent with the approved indications, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was approximately 2 years (range: <6 months to >4 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

In SOLO-1, patients with newly diagnosed advanced BRCAm ovarian cancer, the incidence of MDS/AML was 1.9% (5/260) in patients who received LYNPARZA and 0.8% (1/130) in patients who received placebo based on an updated analysis. In PAOLA-1, of patients with newly diagnosed advanced ovarian cancer with HRD-positive status, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA and 2.3% (3/131) in the control arm.

In SOLO-2, patients with BRCAm platinum-sensitive relapsed ovarian cancer, the incidence of MDS/AML was 8% (15/195) in patients who received LYNPARZA and 4% (4/99) in patients who received placebo. The duration of LYNPARZA treatment prior to the diagnosis of MDS/AML ranged from 0.6 years to 4.5 years.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Including severe and fatal cases, has occurred in patients treated with LYNPARZA. In clinical studies, among patients who received LYNPARZA as a single agent or as part of a combination regimen, the incidence of pneumonitis, including fatal cases, was 1.0% (29/2851). If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and promptly assess the source of the symptoms. If pneumonitis is confirmed, discontinue LYNPARZA treatment and treat the patient appropriately.

Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE), occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

Hepatotoxicity, including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe and potentially fatal cases of DILI has occurred in patients treated with LYNPARZA. Evaluate bilirubin and transaminases at baseline and throughout treatment with LYNPARZA. For patients who develop abnormal liver tests after LYNPARZA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold LYNPARZA. Upon confirmation of DILI, discontinue LYNPARZA.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.

Females
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males
Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (all Grades) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/ bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/sinusitis/rhinitis/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: increase in mean corpuscular volume (89%), decrease in hemoglobin (83%), decrease in leukocytes (69%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), increase in serum creatinine (44%), and decrease in platelets (42%).

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (all Grades) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abirateronewith a difference of ≥5% compared to placebo/abiraterone for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%).

Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:

  • a deleterious or suspected deleterious BRCA mutation, and/or
  • genomic instability

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

Maintenance BRCA-mutated Recurrent Ovarian Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer
For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-Negative Metastatic Breast Cancer
For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone
In combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information, including Medication Guide.

References

  1. National Cancer Institute. BRCA Gene Changes: Cancer Risk and Genetic Testing. Accessed January 15, 2025. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
  2. National Breast Cancer Foundation. BRCA: The Breast Cancer Gene. January 15, 2025. https://www.nationalbreastcancer.org/what-is-brca/
  3. Li H, Liu ZY, Wu N, Chen YC, Cheng Q, Wang J. PARP inhibitor resistance: The underlying mechanisms and clinical implications. Mol Cancer. 2020;19:1-16.
  4. Taylor KN, Scott M. PARP inhibitors: Choosing what to use in epithelial ovarian cancer. Accessed January 15, 2025. https://www.contemporaryobgyn.net/view/parp-inhibitors-choosing-what-to-use-in-epithelial-ovarian-cancer
  5. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.
  6. Mandapati A, Lukong KE. Triple negative breast cancer: approved treatment options and their mechanisms of action. J Cancer Res Clin Oncol. 2023;149:3701–3719.
  7. Tung N, Garber JE. PARP inhibition in breast cancer: progress made and future hopes. NPJ Breast Cancer. 2022;8(1):47.
  8. Cortesi L, Rugo HS, Jackisch C. An Overview of PARP Inhibitors for the Treatment of Breast Cancer. Targ Oncol. 2021;16:255–282.
  9. Garber JE. GS1-09: OlympiA- Phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1/BRCA2 pathogenic variants & high risk HER2- negative primary breast cancer. Presented at: San Antonio Breast Cancer Symposium. December 11, 2024.
  10. Redig AJ, McAllister SS. Breast cancer as a systemic disease: a view of metastasis. J Intern Med. 2013;274(2):113–126.
  11. American Cancer Society. About Breast Cancer. Accessed January 15, 2025. https://www.cancer.org/content/dam/CRC/PDF/Public/8577.00.pdf
  12. US Food and Drug Administration. FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer. Accessed January 15, 2025. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-gbrcam-her2-negative-locally-advanced-or-metastatic-breast-cancer
  13. 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.
  14. Mahtani R, et al. BRCA1/2 Mutation Testing in Patients with HER2-Negative Advanced Breast Cancer: Real-World Data from the United States, Europe, and Israel. Cancers (Basel). 2022;14:5399.
  15. Lux MP, Fasching PA. Breast Cancer and Genetic BRCA1/2 Testing in Routine Clinical Practice: Why, When and For Whom? Geburtshilfe Frauenheilkd. 2023;83(3):310-320.
  16. Lau-Min KS, McCarthy AM, Nathanson KL, Domchek SM. Nationwide Trends and Determinants of Germline BRCA1/2 Testing in Patients With Breast and Ovarian Cancer. J Natl Compr Canc Netw. 2023;21(4):351-358.e4.