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
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.
The following organizations offer peer support services for people with or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Who covered this study?
MEDPAGETODAY
Promising Phase III Results in HR+/HER2- Breast Cancer
This article rates 4.0 out of 5
stars
OncLive
Elacestrant Secures a Place for ER+, HER2–, ESR1-Mutated Advanced/Metastatic Breast Cancer
This article rates 3.0 out of 5
stars