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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Excerpt:
...only for patients enrolled in the US`Progression Free Survival (PFS) based upon investigator assessment of progression between patients in the two treatment arms in the subset of patients with tumors bearing a PIK3CA mutation.`...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

Excerpt:
...Pre-registration PIK3CA Mutant Inclusion...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1932MO - Ki67 expression and CDK4/6i activity: An emerging role for PIK3CA mutations in metastatic breast cancer patients

Published date:
09/18/2020
Excerpt:
...the present study evaluated the impact of PI3K mutations on treatment outcome in metastatic BC (mBC) patients (pts) receiving CDK4/6i in association with hormonal therapy as per approved indication….Thirty pts treated with palbociclib (n=26) or ribociclib (n=4) plus hormonal therapy were enrolled....The univariate and multivariate analysis comparing PFS and clinically relevant data (i.e., age, metastasis, previous lines of hormonal or chemotherapy), confirmed PI3K as the only biomarker significantly associated to PFS (p=0.01).
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Detection of actionable gene mutations in breast cancer by amplicon-based next-generation sequencing liquid biopsy.

Published date:
05/13/2020
Excerpt:
An association was seen between PIK3CA mutation and prior treatment with CDK4/6 inhibitors (palbociclib, ribociclib) or mTOR inhibitor (everolimus), with 58% of PIK3CA-mutant cases having received these treatment previously compared to only 20% of PIK3CA-wild type (wt) cases.
DOI:
10.1200/JCO.2020.38.15_suppl.1035