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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | fulvestrant (Selective estrogen receptor degrader) |
| Direction: | Resistant |
Evidence:
Source:
Title:
5165 - The genomic landscape and prognostic implications of somatic alterations in patients (pts) with ER+, HER2-, PIK3CA mutated (mut) advanced breast cancer treated with taselisib and fulvestrant
Published date:
03/09/2022
Excerpt:
The top altered genes were TP53 (44%), ESR1 (37%), CDH1 (17%), FGFR1 (12%), NF1 (11%), CHEK2 (10%), and PTEN (9%). In pts treated with PBO+FUL, alterations in PTEN (HR 2.8; 95% CI 1.4-5.7; p=0.0107) and TP53 (HR 2.0; 95% CI 1.3-3.1; p=0.0025) were associated with a worse prognosis compared to pts with no mutation detected (NMD) in these genes. In pts treated with TAS+FUL, alterations in FGFR1 (HR 2.4; 95% CI 1.5-3.7; p=0.0006), TP53 (HR 1.9; 95% CI 1.4-2.6; p=0.0001) and PTEN (HR 1.8; 95% CI 1.1-2.8; p=0.0265) were associated with a worse prognosis compared to pts with NMD in these genes.We report that the most frequently mutated genes identified are consistent with previous studies in pts with ER+, HER2- aBC. This analysis shows that alterations in TP53 and PTEN were associated with poor prognosis in both tx arms, and FGFR1 alterations were associated with a poor prognosis in TAS+FUL treated pts. Further, NF1 alterations were associated with a poor prognosis in PBO+FUL treated pts, an association that was not observed with TAS+FUL.
Trial ID:
Source:
Title:
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Excerpt:
...- Known TP53 mutation status....
Trial ID:
Source:
Title:
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2â' Breast Cancer with an ESR1 Mutation
Excerpt:
...Examples may include, but not be limited to, the mutations Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, and Y537N or other ESR1 missense mutation(s) between codons 310 and 547 known to induce protein changes to the ESR1 binding domain. ...
Trial ID:
