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Association details:
| Biomarker: | ESR1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial
Published date:
09/29/2022
Excerpt:
The PADA-1 trial aimed to show the efficacy of an early change in therapy on the basis of a rising ESR1 mutation in blood (bESR1mut), while assessing the global safety of combination fulvestrant and palbociclib….. Median progression-free survival from random assignment was 11·9 months (95% CI 9·1–13·6) in the fulvestrant and palbociclib group versus 5·7 months (3·9–7·5) in the aromatase inhibitor and palbociclib group (stratified HR 0·61, 0·43–0·86; p=0·0040)....n PADA-1 is the first prospective randomised trial showing that the early therapeutic targeting of bESR1mut results in significant clinical benefit.
Secondary therapy:
fulvestrant
DOI:
10.1016/S1470-2045(22)00555-1
Trial ID:
Source:
Title:
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
Excerpt:
...Progression-free survival`Prevalence of ESR1 and PI3K mutations...
Trial ID:
Source:
Title:
A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.
Excerpt:
...Provision of blood sample to test ESR1 mutation status and for other biomarker assessment....
Trial ID:
More C2 evidence
Source:
Title:
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Excerpt:
...Incidence of treatment-emergent Adverse Events`To assess whether a change of the hormone therapy associated with palbociclib will benefit patients for whom rising ESR1 mutations are detected during treatment with palbociclib and aromatase inhibitor. ...
Trial ID:
Source:
Title:
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
Excerpt:
...Estrogen Receptor 1 (ESR1) mutational status will be determined in circulating free DNA (cDNA) obtained from baseline plasma samples and will be prospectively determined before the interims or final analyses. ...
Trial ID:
