Granted Patent
B2
US 12,487,242 · App. 17/652,466 · Granted Dec 2, 2025
DCIS recurrence and invasive breast cancer
Assignee:
Prelude Corporation
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Abstract
The present technology generally relates to methods and compositions relevant to the prediction that a subject with and/or after treatment for DCIS will experience a subsequent ipsilateral breast event that is a DCIS recurrence, an invasive breast cancer, both a DCIS recurrence and invasive cancer, or neither. The technology can assist one with how to treat such subjects.
Claims (55)
1 . A method for treating a subject, said method comprising:
providing a DCIS sample from a subject;
analyzing the DCIS sample for at least:
PR, HER2, and SIAH2 expression levels, and patient menopausal status by measuring presence/absence and/or measuring expression levels of PR, HER2, SIAH2, and obtaining menopausal status; or
PR, HER2, and SIAH2 expression levels by measuring presence/absence and/or measuring expression levels of PR, HER2, and SIAH2,
wherein the analyzed DCIS sample is determined to be at least:
PR−, HER2−, and SIAH2−; or
PR−, HER2−, SIAH2−, and pre-menopausal; and
based on determining that the DCIS sample is (1) PR−, HER2−, and SIAH2−, or (2) PR−, HER2−, SIAH2−, and pre-menopausal, treating the subject with at least one of:
adjuvant radiation; or
endocrine therapy,
thereby reducing the subject's risk of subsequent ipsilateral invasive breast cancer.
2 . The method of claim 1 , further comprising analyzing the sample for the set of biomarkers: p16, COX2, and KI67 expression levels.
3 . The method of claim 1 , wherein analysis of the at least PR, HER2, and SIAH2 expression levels is carried out in parallel with each other.
4 . The method of claim 1 , wherein analysis of the at least PR, HER2, and SIAH2 expression levels is carried out at overlapping times.
5 . The method of claim 1 , wherein PR analysis precedes an analysis of one or more other markers, wherein the one or more other markers is selected from the group consisting of HER2, SIAH2, FOXA1, COX2, p16, and KI67.
6 . The method of claim 5 , wherein the analysis of the one or more other markers is performed based on the result of the PR analysis, wherein the one or more other markers is selected from the group consisting of FOXA1, COX2, p16, and KI67.
7 . The method of claim 1 , wherein measuring the presence/absence and/or measuring the expression levels of PR, HER2, and SIAH2 comprises measuring a RNA level or a protein level of PR, HER2, and SIAH2.
8 . The method of claim 1 , wherein the PR expression level is, or is a corresponding value of, a percentage of PR nuclear signal in DCIS cells of the DCIS sample by IHC staining, and wherein PR− is present in the DCIS sample when the percentage of PR nuclear signal is less than 10%.
9 . The method of claim 1 , wherein the SIAH2 expression level is, or is a corresponding value of, a percentage of SIAH2 nuclear signal in DCIS cells of the DCIS sample by IHC staining, and wherein SIAH2− is present in the DCIS sample when the percentage of cells with SIAH2 nuclear signal is 20% or less.
10 . The method of claim 1 , wherein the endocrine therapy comprises tamoxifen or an aromatase inhibitor.
11 . The method of claim 1 , wherein the SIAH2 expression level is, or is a corresponding value of, a percentage of SIAH2 nuclear signal in DCIS cells of the DCIS sample by IHC staining, and SIAH2− is present in the DCIS sample when the percentage of cells with SIAH2 nuclear signal is less than 10%.
12 . A method for recommending and providing a treatment to a subject, said method comprising:
receiving a DCIS sample from a subject;
analyzing the DCIS sample for at least:
PR, HER2, and SIAH2 expression levels, and patient menopausal status by measuring presence/absence and/or measuring expression levels of PR, HER2, SIAH2, and obtaining menopausal status; or
PR, HER2, and SIAH2 expression levels by measuring presence/absence and/or measuring expression levels of PR, HER2, SIAH2,
wherein the analyzed DCIS sample is determined to be at least:
PR−, HER2−, and SIAH2−; or
PR−, HER2−, SIAH2−, and pre-menopausal;
based on determining that the DCIS sample is (1) PR−, HER2−, and SIAH2−, or (2) PR−, HER2−, SIAH2−, and pre-menopausal, recommending at least one of the following treatments:
adjuvant radiation; or
endocrine therapy; and
administering the recommended treatment to the subject, thereby reducing the subject's risk of subsequent ipsilateral invasive breast cancer.
13 . The method of claim 12 , further comprising analyzing the sample for the set of biomarkers: p16, COX2, and KI67 expression levels.
14 . The method of claim 12 , wherein analysis of the at least PR, HER2, and SIAH2 expression levels is carried out in parallel with each other.
15 . The method of claim 12 , wherein analysis of the at least PR, HER2, and SIAH2 expression levels is carried out at overlapping times.
16 . The method of claim 12 , wherein PR analysis precedes an analysis of one or more other markers, wherein the one or more other markers is selected from the group consisting of HER2, SIAH2, FOXA1, COX2, p16, and KI67.
17 . The method of claim 16 , wherein the analysis of the one or more other markers is performed based on the result of the PR analysis, wherein the one or more other markers is selected from the group consisting of FOXA1, COX2, p16, and KI67.
18 . The method of claim 12 , wherein measuring the presence/absence and/or measuring the expression levels of PR, HER2, and SIAH2 comprises measuring a RNA level or a protein level of PR, HER2, and SIAH2.
19 . The method of claim 12 , wherein the PR expression level is, or is a corresponding value of, a percentage of PR nuclear signal in DCIS cells of the DCIS sample by IHC staining, and wherein PR− is present in the DCIS sample when the percentage of PR nuclear signal is less than 10%.
20 . The method of claim 12 , wherein the SIAH2 expression level is, or is a corresponding value of, a percentage of SIAH2 nuclear signal in DCIS cells of the DCIS sample by IHC staining, and wherein SIAH2− is present in the DCIS sample when the percentage of cells with SIAH2 nuclear signal is 20% or less.
21 . The method of claim 12 , wherein the endocrine therapy comprises tamoxifen or an aromatase inhibitor.
22 . The method of claim 12 , wherein the SIAH2 expression level is, or is a corresponding value of, a percentage of SIAH2 nuclear signal in DCIS cells of the DCIS sample by IHC staining, and wherein SIAH2− is present in the DCIS sample when the percentage of cells with SIAH2 nuclear signal is less than 10%.
23 . A method of reducing a risk of subsequent ipsilateral invasive breast cancer in a subject having DCIS, said method comprising:
providing a DCIS sample from the subject;
determining that the DCIS sample is at least:
PR−, HER2−, and SIAH2−; or
PR−, HER2−, SIAH2−, and pre-menopausal
based on determining that the DCIS sample is (1) PR−, HER2−, and SIAH2−, or (2) PR−, HER2−, SIAH2−, and pre-menopausal, the subject receiving adjuvant radiation or endocrine therapy for treatment of the DCIS, thereby reducing a risk of subsequent ipsilateral invasive breast cancer.
24 . The method of claim 23 , wherein receiving adjuvant radiation or endocrine therapy for treatment of DCIS is further based on determining that the sample is p16', COX2+, and KI67+.
25 . The method of claim 23 , wherein the determination is based on a RNA level or a protein level of PR, HER2, and SIAH2.
26 . The method of claim 23 , wherein the DCIS sample is determined to be PR-when a percentage of PR nuclear signal in DCIS cells of the DCIS sample by IHC staining, or a corresponding value thereof, is less than 10%.
27 . The method of claim 23 , wherein the DCIS sample is determined to be SIAH2− when a percentage of SIAH2 nuclear signal in DCIS cells of the DCIS sample by IHC staining, or a corresponding value thereof, is 20% or less.
28 . The method of claim 23 , wherein the endocrine therapy comprises tamoxifen or an aromatase inhibitor.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 26, 2025
From: BREMER, TROY M.; LINKE, STEVEN PAUL
To: PRELUDE CORPORATION
Reel/Frame 070640/0888 →
Continuity (3)
Continuation
15529966
Provisional Application
62088132
· Dec 5, 2014
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