NCI-2023-01854

A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer

This research study is comparing two CDK4/6 inhibitors (ribociclib and palbociclib) in patients with advanced, hormone receptor-positive breast cancer that is HER2-negative but with the HER2-enriched subtype which a subtype of HER2-negative breast cancer where the HER2 gene is still active at higher-than-normal levels without the protein overexpression. This subtype may behave differently and respond differently to treatments than other HER2-negative cancers. The goal is likely to determine if one of these drugs is more effective or has fewer side effects in this specific patient population.

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.

Hormone Receptor positive: It is a type of breast cancer where the cancer cells have receptors on their surface that can attach to hormones in the body, particularly estrogen and/or progesterone. When these receptors attach to hormones, they can stimulate the cancer cells to grow.

Advanced: Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

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

https://clinicaltrials.gov/ct2/show/NCT05207709

Clinical Trial Site: Einstein

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