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MAINTAIN Trial: Ribociclib Extends PFS

First randomized evidence supporting the switch of ET + Ribociclib following progression on a prior CDK4/6 inhibitor

Study Architecture

Population: HR+/HER2- Metastatic Breast Cancer.

History: Progressed on prior ET + CDK4/6i (87% Palbociclib).

Design: Phase II, Randomized, Double-Blind (n=119).

INTERVENTION (n=60) Switch ET + Ribociclib
CONTROL (n=59) Switch ET + Placebo

43%

Reduction in Risk of Progression or Death

HR: 0.57 (P = .006)

Median Progression-Free Survival (Months)

12-Month PFS Rate

Difference: +17.2 pp
≈3.3× higher

Safety Profile

Grade 3 Neutropenia:

Ribo
38%
Placebo
0%

*Febrile neutropenia was rare (n=2).

Clinical Recommendation: Switching to Ribociclib + different ET is an effective, evidence-based strategy for patients progressing on a prior CDK4/6 inhibitor (specifically Palbociclib).

Abbreviations

  • PFS — progression-free survival (выживаемость без прогрессирования)
  • HR — hazard ratio (отношение рисков)
  • ET — endocrine therapy (эндокринная терапия)
  • CDK4/6i — ингибитор CDK4/6
  • HR+/HER2- — гормон-рецептор-позитивный / HER2-негативный
  • n — число пациентов
Source: Kalinsky, K. et al. Endocrine therapy switch with or without ribociclib after progression on CDK4/6 inhibitor therapy in HR+/HER2− metastatic breast cancer (MAINTAIN). J. Clin. Oncol. 41, 4184–4195 (2023).
ArmRibociclib
12-mo PFS (%)24.6
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