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US 11,530,448 B2Granted
Integration of tumor characteristics with breast cancer index
AssigneeBiotheranostics, Inc.
InventorsYi Zhang, Catherine A. Schnabel
Life of this patent
Estimating the term…
Abstract
Methods of determining risk of recurrence of a breast cancer of a subject are provided. Also provided are methods of predicting responsiveness to a therapy of a breast cancer of a subject. Additionally, methods of recommending treatment for a subject that has breast cancer are provided. Further provided are methods of treating a subject that has breast cancer. Systems for performing described methods are also provided.
Claims19
A method of treating breast cancer of a subject who is lymph node-positive, the method comprising
- (i) determining that the subject has a BCIN+numerical score above 7 by:
- assaying or having assayed a sample of breast cancer cells from the subject for the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2;
- summing or having summed the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2 as a single index into a subject's MGI index;
- assaying or having assayed the sample of breast cancer cells from the subject for the expression levels of HOXB13 and IL17BR;
- calculating or having calculated the ratio of the expression levels of HOXB13/IL17BR to obtain the subject's H/I ratio;
- summing or having summed the subject's H/I ratio with the subject's MGI index to obtain a subject's BCI numerical score;
- determining or having determined one or more clinicopathological factor selected from tumor size and grade of the subject's breast cancer;
- and
- calculating or having calculated the BCIN+numerical score of the subject by combining the BCI numerical score with the one or more clinicopathological factor of the subject using a multivariate Cox-proportional model;
- and
- (ii) treating the subject with
- (a) endocrine therapy, if the subject has previously been treated for breast cancer, or
- (b) paclitaxel with 5-fluorouracil, doxorubicin and cyclophosphamide, if the subject has not previously been treated for breast cancer.
10 more elements
A method of treating breast cancer of a subject who is lymph node-positive, the method comprising
- (i) determining that the subject has a BCIN+numerical score above a BCIN+numerical score cut point by:
- assaying or having assayed a sample of breast cancer cells from the subject for the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2;
- summing or having summed the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2 as a single index into a subject's MGI index;
- assaying or having assayed the sample of breast cancer cells from the subject for the expression levels of HOXB13 and IL17BR;
- calculating or having calculated the ratio of the expression levels of HOXB13/IL17BR to obtain the subject's H/I ratio;
- summing or having summed the subject's H/I ratio with the subject's MGI index to obtain a subject's BCI numerical score;
- determining or having determined one or more clinicopathological factor selected from tumor size and grade of the subject's breast cancer;
- calculating or having calculated the BCIN+numerical score of the subject by combining the BCI numerical score with the one or more clinicopathological factor of the subject using a multivariate Cox-proportional model;
- comparing or having compared the BCIN+numerical score of the subject to the BCIN+numerical score cut point pre-determined based on the BCIN+numerical scores calculated for a training set of samples containing breast cancer tissues from patients that were responsive to endocrine therapy and patients that were not responsive to endocrine therapy;
- and
- (ii) treating the subject with endocrine therapy.
8 more elements
A method of treating breast cancer of a subject who is lymph node-positive, the method comprising
- (i) determining that the subject has a BCIN+numerical score above a BCIN+numerical score cut point by:
- assaying or having assayed a sample of breast cancer cells from the subject for the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2;
- summing or having summed the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2 as a single index into a subject's MGI index;
- assaying or having assayed the sample of breast cancer cells from the subject for the expression levels of HOXB13 and IL17BR;
- calculating or having calculated the ratio of the expression levels of HOXB13/IL17BR to obtain the subject's H/I ratio;
- summing or having summed the subject's H/I ratio with the subject's MGI index to obtain a subject's BCI numerical score;
- determining or having determined one or more clinicopathological factor selected from tumor size and grade of the subject's breast cancer;
- calculating or having calculated the BCIN+numerical score of the subject by combining the BCI numerical score with the one or more clinicopathological factor of the subject using a multivariate Cox-proportional model;
- comparing or having compared the BCIN+numerical score of the subject to the BCIN+numerical score cut point pre-determined based on the BCIN+numerical scores calculated for a training set of samples containing breast cancer tissues from patients that had breast cancer recurrence and patients that did not have breast cancer recurrence;
- and
- (ii) treating the subject with endocrine therapy if.
8 more elements
Dependencies are inferred from the claim text.