| Title |
NOVARTIS-An open-label, multicenter, Phase IIIb study to assess ribociclib (LEE011) for the treatment of advanced breast cancer (aBC) |
| Description |
This open-label, single-arm, multi-center Phase IIIb study will evaluate the overall safety, tolerability and clinical efficacy of ribociclib in combination with letrozole in men and postmenopausal women with HR+, HER2- aBC without prior hormonal treatment for advanced disease. A total of approximately 3,000 patients will be enrolled for treatment with Letrozole (2.5 mg once daily) + Ribociclib (LEE011) 600 mg (day 1 to 21 in a 28-day cycle). Patients will receive trial cancer treatment until disease progression, unacceptable toxicities, physician decision, subject/guardian’s decision, protocol deviation, study termination by the sponsor, lost to follow-up, technical problems, or until 24 months after LPFV, whichever event occurs first. |
| NCT Number |
02941926 |
| Notes |
Men and postmenopausal women with HR+(hormone receptor-positive)/HER2-negative metastatic or advanced breast cancer are invited to participate. Additional information can be found on ClincalTrials.gov |
| Start Date |
12/05/2016 |
| Status |
Enrolling |
| Principal Name |
Kerry Pulver, MD |
| Contact Name |
Erin Hawks, CCRC |
| Phone |
208-367-7165 |
