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PENELOPE-B tested whether a year of the CDK4/6 inhibitor palbociclib after chemotherapy and surgery would prevent recurrence in women at high risk; it did not, one of two trials to show that palbociclib does not work in early breast cancer even though later drugs in the class do.
PENELOPE-B randomised 1250 women with hormone receptor-positive, HER2-negative breast cancer who still had invasive disease at surgery after neoadjuvant chemotherapy, and a high clinical-pathological risk score, to 13 cycles of palbociclib or placebo alongside standard endocrine therapy. The primary endpoint was invasive disease-free survival.
Palbociclib did not improve invasive disease-free survival; an early separation of the curves disappeared with longer follow-up. Together with PALLAS, which tested two years of palbociclib in a broader population, it showed that palbociclib has no role in early breast cancer, while abemaciclib (monarchE) and ribociclib (NATALEE) proved effective, a reminder that the class does not behave as one drug.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,250 enrolled.
Stratified hazard ratio with 95% repeated CI; 1250 randomised; 308 events; median follow-up 42.8 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survivalprimary | Palbociclib + endocrine therapy | - | Stratified hazard ratio with 95% repeated CI; 1250 randomised; 308 events; median follow-up 42.8 months | 0.93 (0.74 to 1.17) | 0.525 | link |
| Placebo + endocrine therapy | - | - |
Shares Palbociclib, CDK4/6 inhibitors, Pfizer (incl. Seagen), Breast cancer (all types) and the tag subtype-trials.
Shares Breast cancer (all types), HR-positive / HER2-negative breast cancer and the tag subtype-trials.
Shares Sibylle Loibl and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.