NATALEE: three years of ribociclib after surgery in a broad population of hormone-receptor-positive early breast cancer
Three years of the CDK4/6 inhibitor ribociclib added to hormone therapy reduced relapses in stage II-III hormone-receptor-positive breast cancer, including some node-negative patients.
Open-label phase 3 trial of 5,101 patients with hormone-receptor-positive, HER2-negative stage II or III early breast cancer, including node-negative patients with high-risk features, randomised to a non-steroidal aromatase inhibitor with or without three years of ribociclib at a reduced dose (400 mg daily). Primary endpoint was invasive disease-free survival.
Three-year iDFS was 90.4% vs 87.1% (HR 0.75). Together with monarchE it established adjuvant CDK4/6 inhibition, but in a broader, lower-risk population and with a longer, lower-dose schedule.
- Three-year invasive disease-free survival 90.4% vs 87.1%; HR 0.75 (95% CI 0.62-0.91).
- Benefit was consistent across stage II and III and in node-negative and node-positive subgroups.
- Distant disease-free survival HR 0.74.
- Grade 3 or higher neutropenia in roughly 44% and liver enzyme elevation in roughly 8% of ribociclib patients; about one in five discontinued for adverse events.
- Overall survival immature at the primary analysis.
Ribociclib is a second adjuvant CDK4/6 option, and the only one with data in node-negative stage II disease. Roughly 3 in 100 patients avoid a relapse or death at three years, so the decision depends heavily on individual risk, tolerance of a three-year oral drug, and cost. Whether the benefit persists after treatment ends, as it did with abemaciclib, needs longer follow-up.
- Absolute benefit at three years is about 3 percentage points and the trial included many patients whose baseline risk was modest.
- Follow-up beyond the three years of treatment is limited, so durability is not yet established.
- Open-label; a large proportion of patients stopped ribociclib early.
- Cost of three years of therapy is substantial; cost-effectiveness has been questioned in several health systems.
Pages like this
not linked directly; found by shared links- Key papermonarchE: two years of abemaciclib after surgery in high-risk, hormone-receptor-positive early breast cancer
Shares monarchE, NATALEE, Miguel Martín, CDK4/6 inhibitors.
- TrialMONALEESA-2
Shares Ribociclib, CDK4/6, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
- PersonDebu Tripathy
Shares Ribociclib, CDK4/6, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
- PathwayThe cell-cycle engine (cyclins & CDKs)
Shares Ribociclib, CDK4/6 inhibitors, CDK4/6, Estrogen receptor (ERα).
- ProductAbemaciclib
Shares monarchE, Miguel Martín, CDK4/6 inhibitors, CDK4/6.
- IdeaUse residual disease tests to decide who needs ten years of hormone therapy
Shares monarchE, Endocrine therapy (SERMs, AIs, SERDs), Dormant cells and minimal residual disease, HR-positive / HER2-negative breast cancer.
- PairingCDK4/6 inhibitor + endocrine therapy
Shares Ribociclib, CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
- PathwayOestrogen receptor signalling
Shares Ribociclib, CDK4/6 inhibitors, CDK4/6, Estrogen receptor (ERα).