NCI-2019-06939

A Phase 1/2, open-label, dose escalation, and cohort expansion clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ARV-471 alone and in combination with Palbociclib (IBRANCE) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting

This study is trying out a new treatment called ARV-471 for people who have Estrogen Receptor positive HER-2 negative breast cancer. The patients they're looking at are those who have breast cancer that has grown a lot in the area around the breast or has spread to other parts of the body. These patients have already received treatments like hormonal therapy (to block the hormones that fuel the cancer) and chemotherapy (strong medicines to fight the cancer cells) in the more advanced stages of their disease. The study will be done in two parts: Phase 1: They'll start with a small dose of ARV-471 and see how people react to it. If it seems safe, they'll increase the dose slowly to find the best amount that works well without causing too many side effects. Phase 2: Once they find the right dose from Phase 1, they'll test that dose on a larger group of patients to get a better idea of how well it works. Some patients in this phase will also take ARV-471 with another medicine called Palbociclib (also known as IBRANCE).

Estrogen Receptor positive HER-2 negative: It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.

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

https://clinicaltrials.gov/ct2/show/NCT04072952

NCI-2019-06939

Clinical Trial Site: Einstein

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