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Guideline: ASCO guidelines recommend olaparib for people with early-stage, high-risk breast cancer and an inherited BRCA mutation

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At a glance Clinical trials
Updated guidelines Guidelines
What does this mean for me? Questions for your doctor
In-depth: Research behind the update Resources



What is this guideline about?

The American Society of Clinical Oncology (ASCO) updated its guidelines on the management of hereditary breast cancer. The new guidelines now include a recommendation to add one year of the oral olaparib as for people with (or nonmetastatic), breast cancer who have an inherited or mutation and who are at high risk for recurrence. Update: Based on results from the OlympiA Study, on March 11, 2022 the approved as treatment for people with an inherited mutation who have been diagnosed with HER2-negative breast cancer and are at high risk for recurrence. 


Why is this guideline important?

Most people with breast cancer may be treated successfully and never have their cancer return. Some people, however, particularly those with large tumors, several positive or may have an increased risk for recurrence after treatment ends.

Several methods are used to treat breast cancer, including surgery, radiation therapy and hormone therapy. In people with breast cancer, a year of such as Herceptin (used for breast cancers) may be used after treatment to keep cancer from coming back. Until , no was available to specifically keep cancer from returning in people with a or mutation.

PARP inhibitors are a type of that was developed to kill cancer cells in people with a mutation. These medicines prevent cancer cells from repairing damage, leading to cancer cell death. PARP inhibitors for breast cancer are only approved to treat people with breast cancer.

In June 2021, the early results of the large OlympiA study were published. OlympiA looked at whether treatment with a could improve outcomes in women with earlier-stage breast cancer (see our In-depth section for more details). Based on these results ASCO has updated its 2020 guidelines on the treatment of hereditary breast cancer to recommend a year of treatment with the oral olaparib after the completion of chemotherapy for people with all the following:

  • breast cancer
  • breast cancer
  • an in a or a gene
  • an increased risk for recurrence


Updated guidelines

The guidelines below are based on results from the OlympiA trial, a phase 3 clinical trial that included 1,836 people with breast cancer and a or mutation. In this study, people who received the olaparib as an add-on treatment after initial therapy (e.g., surgery, chemotherapy, etc.) had reduced cancer recurrence and prolonged life. (All clinical trial participants had breast cancer.)

Based on these results, ASCO updated their recommendations to include offering one year of to the following people with breast cancer and a or mutation after completion of or and local treatment (surgery and, or radiation).

  • For people with who had surgery to remove their cancer before chemotherapy:
    • anyone with a tumor that was larger than 2 cm (3/4 inch)
    • anyone with 1 or more positive
  • For people with who had chemotherapy:
    • anyone with residual cancer found at the time of the surgery
  • For people with ER-positive, cancer who had surgery to remove the cancer first (before chemotherapy or hormone therapy):
    • anyone with 4 or more positive
  • For people with ER-positive, cancer who had therapy
    • anyone with residual cancer found at the time of surgery and a high risk for recurrence based on a “CSP+EG score” (a score used to predict outcomes after chemotherapy) of 3 or higher 


What does this mean for me?

If you have a or mutation and you have been diagnosed with , breast cancer, you may benefit from additional treatment with .

If you have been diagnosed with , breast cancer and you do not know if you have a or mutation, genetic testing for an can help you learn if you might benefit from additional treatment with .

Although use of has been added to the ASCO and NCCN guidelines for breast cancer, it is important to note that has not yet received approval in the breast cancer setting, and some health plans may not cover the cost for this treatment.


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posted 8/6/21



ASCO Releases Rapid Guideline Recommendation Update for Certain Patients With Hereditary Breast Cancer. American Society of Clinical Oncology. Published June 15, 2021.

Tung N, Boughey J, Pierce L, et al. Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline. Journal of Clinical Oncology. 2020 Jun 20;38(18):2080-2106. Published online April 3, 2020.

Tutt ANJ, Garber JE, Kaufman B, et al. OlympiA Clinical Trial Steering Committee and Investigators. Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. New England Journal of Medicine. 2021 Jun 24;384(25):2394-2405. Published ahead of print June 3, 2021.



FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People with early-stage HER2-negative breast cancer and an inherited BRCA mutation

This article is also relevant for:

people with breast cancer

people newly diagnosed with cancer

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OlympiA Trial

ASCO recently updated its guidelines on the management of hereditary breast cancer to include the use of for breast cancer in people with an inherited mutation. This change was based on data from the OlympiA phase 3 clinical trial.

is a , a class of drugs that target cancers with defects in homologous repair. is used throughout cancer care to improve treatment outcomes. It is FDA-approved as therapy for ovarian cancer to sustain treatment response in women who have responded at least partially to chemotherapy. is approved to treat men whose cancer no longer responds to medical therapy and has progressed.

For breast cancer, research has shown treatment to be advantageous for or mutations and advanced breast cancer. Before these studies, there has been a lack of data regarding the benefit of PARP inhibitors in people with or mutation with breast cancer.


Researchers of this study wanted to know

The researchers wanted to know if adding a year of olaparib to standard-of-care treatment would be beneficial for people with or mutation who have , breast cancer.


Populations looked at in this study

The study enrolled 1,836 people with an inherited or mutation who had , breast cancer and who were considered to have a high risk for recurrence. Both women and men, as well as people with and hormone-positive breast cancer, were included in the study population.

All patients were required to have completed local therapy (surgery with or without radiation therapy) from two to 12 weeks before entering the trial. Systemic therapies that were undergone by participants before the study could include chemotherapy, and hormone therapy.


Study design

This was a , double-blind study. Patients were randomly assigned to one of two groups:

  • The group received 300mg of twice daily for one year
  • The group received a sugar pill () twice daily for one year


Participants were monitored for:  

  • recurrence of the original breast cancer.
  • new occurrence of cancer.
  • overall survival.
  • Safety, side effects and quality of life in participants for more than 3 years.


Study findings

At the 3-year assessment, research results showed that:

  • recurrence of cancer in the same breast or new cancer in the opposite breast or nearby was less likely to occur in the group (occurred in 11.5% of patients) compared with the group (occurred in 19.4% of patients).
  • distant cancer () occurred in 9.7% of patients in the group and 16.6% of patients in the group.
  • 6.4% of people died of cancer in the group and 9.4% of people died of cancer in the group.
  • Although adverse events were more likely to occur in patients taking compared with , the events were consistent with adverse events associated with the product label (e.g., increased anemia and decreased white blood cell counts).


The results presented were preliminary. Participants will continue to be followed for a total of 10 years.


Strengths and limitations


  • This is a large, international, phase 3, , study that was powered to show overall survival, disease-free survival, safety and quality of life outcomes.
  • The study built on prior studies that showed benefited people with advanced breast cancer who had an inherited and mutation.



OlympiA is an international study, which includes sites in North and South America, Europe, the Middle East and Asia. These preliminary study results did not mention race and ethnicity. This is important because mutations in the or genes can be prevalent among certain racial and ethnic groups, including people of Caribbean and Nigerian descent. While there is no indication that would act differently in different racial groups, specific data from this study is lacking.



PARP inhibitors are FDA-approved to treat advanced breast cancer in patients with inherited or mutations. Research showed that PARP inhibitors as a single-agent delayed recurrence of cancer by three to four months in women with mutation and breast cancer compared with patients who were treated with chemotherapy as a single-agent. In addition, women in the group were more likely to respond to treatment.

The OlympiA trial shows the benefits of the olaparib for patients with an inherited or mutation with , , high-risk breast cancer. Oral medication may be used to improve treatment outcomes for this population.



The current data from the OlympiA Trial suggests that olaparib was effective in reducing recurrence and of cancer and cancer-related death in patients with a or 2 mutation. These findings suggest that more options may be available for people with mutations and breast cancer.   


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posted 8/6/21

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network has guidelines on who should undergo genetic counseling and testing. If you have been diagnosed with breast cancer, you should speak with a genetics expert about genetic testing if any of the following apply to you:     

  • You have a blood relative who has tested positive for an  
  • You have any of the following:  
    • Breast cancer at age 50 or younger  
    • Male breast cancer at any age
    • Ovarian cancer at any age  
    • at any age 
    • Two separate breast cancer diagnoses
    • Eastern European Jewish ancestry and breast cancer at any age 
    • Lobular breast cancer and a family history of diffuse gastric cancer
    • For treatment decisions for people with breast cancer or people with early , breast cancer who are at high-risk for recurrence 
    • Testing of your tumor shows a mutation in a gene that is associated with


  • You have one or more close family members who have had:  
    • Young-onset or rare cancers 
    • Breast cancer at age 50 or younger
    • Male breast cancer, ovarian cancer, pancreatic cancer, or   cancer at any age
    • Two separate cancer diagnoses 
    • prostate cancer or  cancer that is high-risk or very-high-risk group. 

The American Society of Breast Cancer Surgeons (ASBrS) released guidelines in 2019 that recommend all women diagnosed with breast cancer have access to genetic testing for inherited mutations in breast cancer genes. 

If you are uncertain whether you meet the guidelines above and you are interested in or considering genetic testing, you should speak with a cancer genetics expert

Updated: 07/28/2023

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network has guidelines on treating breast cancer in people with an inherited or mutation, with early-onset breast cancer. For people who are at high risk for recurrence, NCCN recommens considering a year of with after chemotherapy is completed.  

Updated: 06/06/2022

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Are PARP inhibitors recommended for my type of breast cancer?
  • Will my insurance pay for treatment?
  • Should I be tested for an in a or gene or another gene that is linked to breast cancer?
  • I have a mutation in a gene other than or BRCA2; would PARP inhibitors be helpful for treating my cancer?
  • How long will I have to use PARP inhibitors?
  • What are the side effects of PARP inhibitors?

Open Clinical Trials
Open Clinical Trials

  • NCT04481113- Abemaciclib and Before Surgery for the Treatment of Hormone Receptor-Positive, Breast Cancer. This phase I trial tests the side effects and best dose of abemaciclib (a kinase inhibitor) and (a ) in treating patients with breast cancer that is positive for or progesterone receptors (hormone receptor-positive [HR+]) and negative. Giving these two drugs together before surgery may reduce the size of the tumor.
  • NCT04584255- + TSR042 In BRCA-Mutated Breast Cancer This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with mutations.
    • The names of the study drugs involved in this study are:
      • ()
      • Dostarlimab

Who covered this study?

Physician’s Weekly

ASCO Updates Recommendations for Managing Hereditary Breast Cancer This article rates 4.0 out of 5 stars

Oncology Nursing News

New ASCO Guideline Recommends Adjuvant Olaparib for Patients with Hereditary Breast Cancer This article rates 4.0 out of 5 stars

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