Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study
726
Total Patients
20.4 mo
Median Follow-up
QOL
Maintained in Both Arms
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Study Design & Arms
Randomized, double-blind, placebo-controlled trial (2:1 ratio).
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Baseline Global Health Status (EORTC QLQ-C30)
Mean baseline scores were well balanced between arms (0-100 scale, higher is better).
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Hazard Ratios: Time to Deterioration (TTD)
HR < 1 favors Ribociclib. Error bars represent 95% CI.
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Median Time to Deterioration (Months)
Comparison of median months until 10% deterioration in scores.
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Change in Pain Scores (8 Weeks)
Change from baseline (Negative is better). Difference not statistically significant.
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Metric Summary
Overview of all extracted metrics and statistical comparisons.
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Appendix: Raw Data & Provenance
| Metric ID | Metric Name | Group | Value | Comparison | Source |
|---|---|---|---|---|---|
| M01 | Baseline Global Health Status/QOL Score (EORTC QLQ-C30) | Ribociclib + fulvestrant | 65.5 (19.1) | - | Table 1 (p.2) |
| M01 | Baseline Global Health Status/QOL Score (EORTC QLQ-C30) | Placebo + fulvestrant | 68.4 (18.5) | - | Table 1 (p.2) |
| M02 | Time to definitive 10% deterioration (TTD) in Global Health Status | Ribociclib + fulvestrant | 35.9 | HR 0.81 (0.62-1.06) | Figure 2a (p.4) |
| M02 | Time to definitive 10% deterioration (TTD) in Global Health Status | Placebo + fulvestrant | 33.1 | - | Figure 2a (p.4) |
| M03 | Time to definitive 10% deterioration (TTD) in Pain Severity Index (BPI-SF) | Ribociclib + fulvestrant | 42.7 | HR 0.77 (0.57-1.05) | Figure 5 (p.6) |
| M03 | Time to definitive 10% deterioration (TTD) in Pain Severity Index (BPI-SF) | Placebo + fulvestrant | 35.9 | - | Figure 5 (p.6) |
| M04 | Time to definitive 10% deterioration (TTD) in Fatigue (EORTC QLQ-C30) | Ribociclib + fulvestrant | 38.7 | HR 0.91 (0.68-1.22) | Figure 3 (p.5) |
| M04 | Time to definitive 10% deterioration (TTD) in Fatigue (EORTC QLQ-C30) | Placebo + fulvestrant | 36.0 | - | Figure 3 (p.5) |
| M05 | Change from baseline in EORTC QLQ-C30 pain scores (8 weeks) | Ribociclib + fulvestrant | -4.0 | Diff -0.3 (CI -4.0 to 3.3) | Page 5, Section 3.4 (p.5) |
| M05 | Change from baseline in EORTC QLQ-C30 pain scores (8 weeks) | Placebo + fulvestrant | -3.6 | - | Page 5, Section 3.4 (p.5) |
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