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Association details:
Evidence:
Evidence Level:
Resistant: B - Late Trials
Source:
Title:

CT189 - Characterization of ESR1 mutations at metastatic relapse and outcome under first line aromatase inhibitor and palbociclib in the PADA-1 trial

Published date:
03/10/2021
Excerpt:
PADA-1 (NCT03079011) is a phase III trial testing the clinical utility of real time ESR1mut detection in the blood of patients treated with AI-Pal. Main inclusion criteria are patients with ER+ HER2- MBC...Presence of ESR1mut detected in cfDNA at metastatic relapse are associated with a shorter PFS under first line AI and palbociclib.
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
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:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Excerpt:
...- Hematological safety of patients with bone metastases will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.- Progression-Free Survival (PFS) will be measured from the time of randomization (following rising ESR1 mutation detection) to the time of tumor progression (as assessed by the investigator per RECIST v1.1) or death (whichever comes first) – in randomized patients....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Excerpt:
...ESR1 mutational status will be blinded to the patients, investigators and study team.`...
Trial ID: