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A French trial that showed, for the first time in a randomised study, that changing hormone therapy when a resistance mutation appears in the blood, before scans change, keeps breast cancer controlled for longer.
PADA-1 (NCT03079011, UNICANCER) enrolled 1,017 women at 83 French hospitals receiving an aromatase inhibitor with palbociclib as first-line treatment for ER-positive, HER2-negative advanced breast cancer and monitored circulating tumour DNA for a rising ESR1 mutation. 279 (27 per cent) developed one and 172 were randomised: switching to fulvestrant plus palbociclib gave a median progression-free survival of 11.9 months against 5.7 months for continuing, stratified hazard ratio 0.61 (Bidard et al., Lancet Oncology 2022). The abstract describes the target as ESR1-mutated subclones that may be sensitive to fulvestrant.
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.
1,017 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival from randomisationprimary | Switch to fulvestrant + palbociclib | 88 | 11.9 months | 0.61 (0.43 to 0.86) | 0.0040 | link |
| Continue aromatase inhibitor + palbociclib | 84 | 5.7 months |
Shares ESR1 mutation (ligand-binding domain, usually in ctDNA), ESR1 mutation, SERENA-6, Estrogen receptor (ERα).
Shares Naming which clone or phenotype is left after treatment, Letrozole (and other aromatase inhibitors), Palbociclib, Fulvestrant.
Shares Naming which clone or phenotype is left after treatment, Palbociclib, Fulvestrant, Circulating tumour DNA (ctDNA).
Shares ESR1 mutation (ligand-binding domain, usually in ctDNA), SERENA-6, Fulvestrant, Estrogen receptor (ERα).
Shares François-Clément Bidard, ESR1 mutation, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
Shares Naming which clone or phenotype is left after treatment, Estrogen receptor (ERα), Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares ESR1 mutation (ligand-binding domain, usually in ctDNA), Letrozole (and other aromatase inhibitors), Palbociclib, Fulvestrant.
Shares Letrozole (and other aromatase inhibitors), Palbociclib, Fulvestrant.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/