At a glance
ClinicalIndex Comparison Record- ✓Histologically and/or cytologically confirmed estrogen-receptor positive and/or progesterone receptor positive, HER2-negative breast cancer
- ✓Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- ✓At least one measurable lesion per RECIST 1.1, or bone lesions (lytic/mixed), or non-measurable disease
- ✓ECOG performance status 0, 1, or 2
- ✕Prior CDK4/6 inhibitor or mTOR inhibitor
- ✕Known hypersensitivity to ribociclib or letrozole excipients
- ✕Current inflammatory breast cancer
- ✕More than 1 prior chemotherapy for advanced/metastatic breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A National Phase IIIb, Multi-center, Open Label Study for Women and Men With Hormone-receptor Positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib (LEE011) in Combination With Letrozole
In Brief
A Phase 3 clinical trial evaluating ribociclib, letrozole, and 1 other intervention for Advanced Metastatic Breast Cancer. Completed, enrolled 502 participants across 84 sites.
Detailed Summary
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients were treated with daily doses of 600 mg ribociclib (3-weeks-on/1-week-off schedule) in combination with 2.5 mg letrozole daily (continuous dosing). Dose adjustments (dose reduction or interruption) according to safety findings were allowed.
Study Details
Timeline
Interventions
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
Premenopausal patients additionally received goserelin 3.6mg as monthly implant