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Content Update

April 19, 2023

Elacestrant Approved for ER-Positive, HER2-Negative, ESR1 Mutated Breast Cancer: The estrogen receptor antagonist elacestrant is U.S. Food and Drug Administration-approved for the treatment of postmenopausal women and adult men with advanced or metastatic ER-positive, HER2-negative, ESR1 mutated breast cancer who have progressed following at least one prior endocrine treatment. An open label phase 3 trial enrolling a total of 477 adult patients compared elacestrant to standard of care (SOC) endocrine monotherapy. Patients were randomized without regard to mutation status, and 48% of patients had an ESR1 mutation. Elacestrant significantly reduced the risk of progression or death compared with SOC by 45% in patients with ESR1 mutation (P = .0005). Common adverse events included fatigue, nausea, and arthralgia.



Upon completion of the chapter, the reader will be able to:

  1. Detail epidemiological and clinical disparities of the disease.

  2. Analyze risk factors associated with, and strategies that can modify the risk of, developing breast cancer.

  3. Summarize the surrogate definitions of the intrinsic breast cancer subtypes.

  4. Recognize signs and symptoms related to early and late stages of the disease.

  5. Distinguish between good and poor prognostic factors.

  6. Determine treatment goals for early-stage, locally advanced, and metastatic breast cancers.

  7. State the rationale for inclusion of adjuvant and neoadjuvant therapies.

  8. Describe the relevance of hormone, HER2, and PD-1 receptors.

  9. Discuss the benefits and risks associated with various therapies.


The growing prevalence of breast cancer in the United States is related to early detection, improved therapies resulting in longer survival and and the relatively high incidence rate. Breast cancer prevalence is increasing in the United States related to early detection, improved therapies resulting in longer survival and the increasing incidence rate. The increased incidence appears to be driven almost exclusively by new breast cancer diagnoses in non-White women.


Breast cancer is the most common type of cancer, and second only to lung cancer as a cause of cancer death, in American women. In 2021, female breast cancer will account for 99% of the projected 284,000 new cases, the median age at diagnosis will be 62 years, and and approximately 43,600 deaths will be attributable to the disease.1 image Even though breast cancer occurs more frequently in non-Hispanic White (nHw) women than any other ethnic group, the mortality rate is highest among African Americans.

Tumor size of most breast cancers at diagnosis is usually small (less than 2 cm), and localized disease predominates in all racial and ethnic groups. However, non-Hispanic Black women have the highest rates of triple-negative breast cancers (TNBCs) and proportionally more cases of advanced disease compared with nHw women. Reduced access to proper medical care, including breast cancer screening programs, as well as certain ...

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