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NCI-2022-09871

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation


This reserach study is looking at two different treatment options for people with a specific type of breast cancer - estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer that has either spread locally or to other parts of the body (metastatic). Additionally, the cancer cells must have a mutation in a gene called ESR1. Treatments being compared: Lasofoxifene and abemaciclib: Lasofoxifene is a medication that works similarly to estrogen in some tissues but blocks its effects in others. Abemaciclib is a drug that slows down the growth of cancer cells. Fulvestrant and abemaciclib: Fulvestrant lowers the levels of estrogen in the body and blocks its effects on cancer cells. Similar to the other treatment, abemaciclib slows down the growth of cancer cells. The study is looking for men and women, both premenopausal and postmenopausal and is open label and randomized.

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:

NCI-2022-09871

Clinical Trial Site: Sinai


To see all available clinical trials click here.



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