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Study: New oral drug treatment for some advanced breast cancer

The FDA has approved a new oral drug called Oserdu for the treatment of HR-positive, HER2-negative advanced breast cancer. A blood test was also approved to help doctors identify patients who would benefit most from this new treatment. (Posted 3/20/23)

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RELEVANCE

Most relevant for: People with HR-positive, HER2-negative advanced breast cancer.

It may also be relevant for:

  • people with breast cancer
  • people with metastatic or advanced cancer
  • people with ER/PR + cancer

Relevance: High

Strength of Science: High

Research Timeline: Post Approval

Relevance rating details

What is this study about?

A research study (called the EMERALD study) looked at how well people with breast cancer did when treated with a new drug called Oserdu (elacestrant). 

The study looked at people with breast cancer that:

  • was metastatic
  • was
  • was
  • came back or got worse after standard treatment

People in the study had received up to two types of treatment before joining the study. Study participants were separated into 2 groups:

  • half of the people receive Oserdu
  • half received standard hormone therapy

Researchers compared how well people in the Oserdu group did compared to people in the standard hormone therapy group. 

During the EMERALD study, a blood test was used to look for a marker found in the cancer known as an ESR1 mutation. ESR1 mutations are made by breast cancers that no longer respond to treatment with a type of hormone therapy known as an aromatase inhibitor (AI).

  • half of the participants had a mutation in ERS1.

What type of treatment is Oserdu?

Oserdu is a type of hormone therapy drug called a selective receptor degrader (SERD). 

Why is this study important?

People with HR-positive, HER2-negative, metastatic breast cancer that comes back or gets worse after treatment have few additional treatment options.

Study findings

The EMERALD study findings included:

  • people who received Orserdu had a longer time until cancer came back or became worse (progression free survival) than people who did not receive Oserdu
  • among people with an ESR1 mutation, those who received Orserdu had a longer time until cancer came back or became worse than people who did not receive Oserdu
  • early results suggest that Orserdu may also increase how long people lived (overall survival) compared to the standard of care but the final overall survival results are not yet available

Side effects

Side effects occurred in most participants, regardless of treatment type. The most common side effects while taking Orserdu included nausea, fatigue, decreased appetite and joint pain.

Side effect Orserdu Hormone therapy
Any 92% 86%
Nausea 35% 19%
Fatigue 19% 19%
Decreased appetite 15% 9%
Joint pain 14% 16%

 

approval

Based on the results of EMERALD, the FDA has approved Orserdu to treat advanced HR-positive, HER2-negative breast cancer. The FDA has also approved a blood test called Guardant360, which tests for tumor mutations in the ESR1 gene. People with an ESR1 tumor mutation benefit most from treatment with Orserdu.

Peer Support

The following organizations offer peer support services for people with or at high risk for breast cancer:

Updated: 05/07/2024