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The trial that made palbociclib the first CDK4/6 inhibitor in routine use. It doubled progression-free time but did not extend life.
PALOMA-2, trial NCT01740427 sponsored by Pfizer and reported in 2016, is the trial that made palbociclib the first CDK4/6 inhibitor in routine use: added to letrozole as first-line treatment for postmenopausal HR-positive, HER2-negative advanced breast cancer it doubled progression-free time but did not extend life. It randomised 666 women, met its primary progression-free survival endpoint, and at the final analysis showed no significant overall survival benefit, with substantial missing survival data; with PALOMA-3 this differentiates palbociclib from ribociclib and abemaciclib on survival. OnCo links it to CDK4/6 as a target, palbociclib, aromatase inhibitors and Richard S. Finn, and the absence of a survival benefit was replicated in PALOMA-3 and the adjuvant PALLAS and PENELOPE-B trials. Whether the three drugs truly differ or the trials did is the open question.
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.
666 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Palbociclib + letrozole | 444 | 27.6 months | 0.56 (0.46 to 0.69) | - | link |
| Placebo + letrozole | 222 | 14.5 months | ||||
| Overall survival | Palbociclib + letrozole | - | 53.9 months | 0.96 (0.78 to 1.18) | - | link |
| Placebo + letrozole | - | 51.2 months |
A second publication from the PALOMA-2 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT01740427 with the most citations, so it is the natural first reading for anyone following the PALOMA-2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, Pfizer (incl. Seagen).
Shares Letrozole (and other aromatase inhibitors), CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Letrozole (and other aromatase inhibitors), Palbociclib, CDK4/6 inhibitors, Pfizer (incl. Seagen).
Shares CDK4/6, Palbociclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Palbociclib and Letrozole in Advanced Breast Cancer, CDK4/6, Palbociclib, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Palbociclib, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares Palbociclib, CDK4/6 inhibitors, Pfizer (incl. Seagen), HR-positive / HER2-negative breast cancer.