Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBMar 20, 2024 · The NATALEE trial is a phase 3 trial comparing ribociclib plus endocrine therapy with endocrine therapy alone that was designed to test CDK4/6 inhibition in a broad population of patients...
NATALEE: Phase III study of ribociclib (RIBO) + endocrine therapy …
WEBMay 26, 2019 · Methods: The phase 3 multicenter, randomized, open-label NATALEE trial will evaluate the efficacy and safety of RIBO + ET as adjuvant treatment in patients with HR+, HER2– EBC. Eligible women (any menopausal status) and men aged ≥ 18 years will be randomized to RIBO 400 mg/day (3 weeks on/1 week off) + ET or ET alone.
Rationale and trial design of NATALEE: a Phase III trial of …
WEBMay 29, 2023 · New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET) versus ET alone in patients with HR+/HER2- early nonmetastatic breast cancer (EBC).
Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBJun 19, 2024 · To the Editor: The recent NATALEE trial (March 21/28 issue) 1 provides compelling evidence of the efficacy of adjuvant ribociclib therapy among patients with breast cancer. However, notable...
NATALEE Trial Long-Term Results on Ribociclib Combination …
WEBJan 25, 2024 · Findings of NATALEE showed that at the July 2023 data cutoff, 1,091 of the 2,549 patients (42.8%) who received the ribociclib-based combination completed 3 years of treatment. Key Results. For the final analysis, median follow-up was 33.3 months.
Ribociclib and endocrine therapy as adjuvant treatment in …
WEBJun 7, 2023 · To investigate whether RIB + ET also improves outcomes in early BC (EBC), the Phase III NATALEE trial (NCT03701334) evaluated adjuvant RIB + ET in a broad population of pts with stage II or III HR+/HER2− EBC at risk for recurrence, including pts with no nodal involvement (N0).
FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB5 days ago · Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2 ...
WEBThe NATALEE results support ribociclib + ET as the treatment of choice in a broad population of pts with stage II or III HR+/HER2 EBC, including pts with N0 disease. Clinical trial information: NCT03701334. Research Sponsor: 2 Novartis Pharmaceuticals Corporation. 2023 by American Society of Clinical Oncology.
Adjuvant Ribociclib Sustains DFS, DDFS Benefit in HR+/HER2– …
WEB6 days ago · In the NATALEE trial, 5101 patients were randomly assigned to receive ribociclib at 400 mg daily as part of a 3-weeks-on, 1-week-off schedule for 3 years plus NSAI (n = 2549) or NSAI alone (n = 2552).
NATALEE Trial: Quality of Life Maintained for Many Patients …
WEBOct 25, 2023 · In the phase III NATALEE trial, the addition of ribociclib to endocrine therapy significantly reduced invasive disease–free survival events by 25%. In a new analysis, investigators reported that health-related quality of life was maintained throughout the duration of treatment.