US 2017/0247766 A1 · LATE ER+ BREAST CANCER ONSET ASSESSMENT AND TREATMENT SELECTION

Abstract

A method for determining the likelihood of late ER− breast cancer disease relapse/recurrence is disclosed. Late ER+ breast cancer disease onset and/or recurrence is determined for a period of 5 to 20 years after an initial ER+ breast cancer disease onset in a patient. An ER+ breast cancer patient is assigned a risk score that is compared to a defined threshold value, and identifies the risk score as low risk or high risk for late breast cancer recurrence. A late ER+ breast cancer gene panel of 8 to 15 genes is provided. Subjects having a risk score greater than or equal to that of the threshold value are at a relatively high risk of recurrent disease, and are determined to benefit from aggressive therapeutic intervention, whereas subjects having a risk score less than the threshold value are at a relatively low risk of recurrent disease, and could forego treatment.

Claims18

Dependent claims

An assessment tool for late ER+ breast cancer recurrence in an at risk human ER+ breast cancer patient comprising a threshold value that defines a reference heterogeneous late ER+ breast cancer marker of heterogeneous late ER+ breast cancer survivor population gene panel levels, wherein the assessment tool partitions an at risk human ER+ breast cancer tissue score into a high risk or a low risk ER+ breast cancer recurrence group.

A method for determining patient risk for late ER+ breast cancer recurrence comprising:

measuring a patient breast cancer tissue sample from an at risk ER+ breast cancer patient for levels of a heterogeneous late ER+ breast cancer survivor population gene panel comprising at least 8 genes;
calculating a patient gene risk score between 0 and 1 for each gene of the gene panel measured in the patient breast cancer tissue sample;
calculating a patient cumulative cancer test score between 0 to 100 from the patient gene risk score values for each gene of the gene panel;
and
comparing said patient cumulative cancer test score to a reference heterogeneous ER+ breast cancer population threshold value;
wherein a patient cumulative cancer test score below about a 60th percentile of the score values in a heterogeneous ER+ breast cancer population indicates a patient with a statistically lower probability of developing late ER+ breast cancer recurrence from 5 to 20 years after an initial ER+ breast cancer occurrence;
and
wherein a patient cumulative cancer test score at least above about a 60th percentile or higher of the score values in a heterogeneous ER+ breast cancer population indicates a patient with a statistically higher probability of developing late ER+ breast cancer recurrence from 5 to 20 years after an initial ER+ breast cancer occurrence.

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Late er+ breast cancer onset assessment and treatment selection

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Late er+ breast cancer onset assessment and treatment selection

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Abstract

Claims18