NCI-2023-03766

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Switching to AZD9833 (a Next Generation, Oral SERD) vs Continuing Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in patients with HR/HER2- early breast cancer and a intermediate or high risk of recurrence who have completed definitive locoregional therapy and at least 2 years of adjuvant endocrine therapy without disease recurrence

This research study is investigating whether switching to a new oral SERD (AZD9833) is more effective and safe compared to continuing standard endocrine therapy (aromatase inhibitor or tamoxifen) for patients with early-stage, hormone receptor-positive, HER2-negative breast cancer who have completed initial treatments and at least 2 years of hormone therapy. AZD9833 is the investigational drug, described as a "next generation, oral SERD (selective estrogen receptor degrader)." SERDs are a type of hormone therapy that block the estrogen receptor in breast cancer cells.

HER-2 Negative: It is a type of breast cancer where cancer cells have normal levels of the protein called HER-2. Cancer cells that are HER-2 negative grow more slowly and are less likely come back or spread to other parts of the body than cancers that have too much HER-2.

Early stage: Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05774951

Clinical Trial Site: Einstein

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