NCI-2022-10269

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbocicliband Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast CancerPreviously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy(VIKTORIA-1)

This research study is trying to figure out if a combination of two medicines, Gedatolisib and Palbociclib, when used with Fulvestrant, works better than the usual treatments for Hormone Receptor-positive HER-2 negative breast cancer. Before joining this study, the patients had already been treated with a specific kind of medicine called a CDK4/6 inhibitor along with another type of drug called a non-steroidal aromatase inhibitor. These medicines were meant to slow down the growth of the cancer. The study is open-label and randomized.

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.

Open-Label: Patients know which treatments are being given to them

Randomized: Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

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

https://clinicaltrials.gov/ct2/show/NCT05501886

NCI-2022-10269

Clinical Trial Site: Einstein

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