PALOMA-2: trial | Bending the Curve: Trial by Trial

Palbociclib and letrozole in advanced breast cancer

Phase 3N = 666NCT01740427

Population

Postmenopausal women with ER-positive, HER2-negative breast cancer and no prior treatment for advanced disease

Design

Double-blind randomized trial, 2:1 allocation to palbociclib plus letrozole or placebo plus letrozole

Primary endpoint

PFS

Arms

People

Finn RS

PFSHR 0.58 (95% CI 0.46–0.72)Δ median PFS+10.3 months

Show the numbers

Results reported for PALOMA-2
Endpoint	Analysis	Palbociclib plus letrozole	Placebo plus letrozole	Effect
PFS	primaryFinn 2016	median 24.8 months	median 14.5 months (12.9–17.1)	HR 0.58 (95% CI 0.46–0.72)P<0.001Investigator-assessed. Upper bound of the palbociclib-arm confidence interval was not estimable (lower bound 22.1 months), so no interval is recorded for that arm.

Results reported for PALOMA-2
Endpoint	Analysis	Palbociclib plus letrozole	Placebo plus letrozole	Effect
PFS	primaryFinn 2016	median 24.8 months	median 14.5 months (12.9–17.1)	HR 0.58 (95% CI 0.46–0.72)P<0.001Investigator-assessed. Upper bound of the palbociclib-arm confidence interval was not estimable (lower bound 22.1 months), so no interval is recorded for that arm.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.58	0.46–0.72

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Appears in

Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016;375(20):1925-1936.
PubMed DOI