Breast Cancer Clinical Trials
A Phase 3 study where men and postmenopausal women with breast cancer are randomly assigned to one of two categories, and neither patients nor their treating physicians will know which category will be assigned to the patient: 1) the study drug alpelisib in combination with fulvestrant, or 2) placebo in combination with fulvestrant (CBYL719C2301).
- Patients must be hormone receptor-positive.
- Patients must be HER2-negative.
- Patients must have advanced breast cancer which has progressed while on, or after receiving treatment with letrozole, anastrozole, or exemestane.
A Phase 3b study to assess ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease (“CompLEEment-1” CLEE011A2404).
- Patients must be male or female with advanced breast cancer recurring in the chest area, or that has metastasized to other areas, and is not suitable for surgical removal.
- emale patients may be pre/perimenopausal, or postmenopausal. However, menopausal status will be assessed. Men and premenopausal women will be given goserelin (suppresses sex hormone).
- Patients must have a confirmed diagnosis of estrogen-receptor positive, and/or progesterone receptor positive breast cancer.
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