received by the International Bureau on 05 June 2017 (05.06.2017)

CLAIMS

1. A method of predicting post-treatment relapse in a patient treated for a HER2-positive breast cancer, wherein the treatment comprises administration of an anti-HER2 antibody and at least an anthracycline and a taxane, comprising:

obtaining a breast cancer sample from the patient and determining in the breast cancer sample at least one of a presence and quantity of a marker selected from the group consisting of TLE3, XRCC1, RRM1, and MGMT; and using the at least one of the presence and quantity of the marker to predict a likelihood of post-treatment relapse in the patient.

2. The method of claim 1 wherein the treatment comprises three administration cycles of FEC (5-fluorouracil (5FU), epirubicin, and cyclophosphamide) and three administration cycles of docetaxel or docetaxel plus gemcitabine.

3. The method of claim 1 wherein the treatment comprises an adjuvant chemotherapy with an anthracycline and a taxane.

4. The method of any of claim 1 or claim 2 wherein the administration of the anti-HER2 antibody is performed over 12 months.

5. The method of claim 1 wherein the step of determining the at least one of the presence and quantity of the marker is performed using at least one of DNA omics analysis, KNA omics analysis, and proteomics analysis.

6. The method of claim 1 wherein the step of determining the at least one of the presence and quantity of the marker is performed using at least two of DNA omics analysis, KNA omics analysis, and proteomics analysis.

7. The method of claim 1 wherein the step of determining the at least one of the presence and quantity of the marker is performed using DNA omics analysis, KNA omics analysis, and proteomics analysis.

8. The method of claim 1 wherein the step of determining the at least one of the presence and quantity of the marker includes at least one of determination of gene copy number, gene expression level, and protein level.

9. The method of claim 1 wherein the step of predicting likelihood of post-treatment relapse in the patient is independent of a size of a primary tumor, a lymph node status, a grade, and a hormone receptor status

10. The method of claim 1 wherein the step of predicting likelihood of post-treatment relapse in the patient is not correlated with a HER2 quantity in the breast cancer sample.

11. The method of claim 1 wherein presence, increased copy number, or increased presence of the marker is predictive of lower likelihood of post-treatment relap3e.

12. Use of presence and/or quantity of at least one of TLE3, XRCC1, RRM1, and MGMT in the prediction of a treatment outcome of a HER2-positive breast cancer, wherein treatment comprises administration of an anti-HER2 antibody and at least an anthracyclme and a taxane.

13. The use of claim 12 wherein the treatment comprises three administration cycles of FEC (5-fluorouracil (5FU), epirubicin, and cyclophosphamide) and three admrnistration cycles of docetaxel or docetaxel plus gemcitabine.

14. The use of claim 12 wherein the treatment comprises an adjuvant chemotherapy with an anthracyclme and a taxane.

15. The use of any of claim 13 or claim 14 wherein the administration of the anti-HER2 antibody is performed over 12 months.

16. The use of claim 12 wherein the presence and/or quantity are determined using at least one of DNA omics analysis, RNA omics analysis, and proteomics analysis.

17. The use of claim 12 wherein the presence and/or quantity are determined using at least two of DNA omics analysis, RNA omics analysis, and proteomics analysis.

18. The use of claim 12 wherein the presence and/or quantity are determined using DNA omics analysis, RNA omics analysis, and proteomics analysis.

19. The use of claim 12 wherein the presence and/or quantity are detertnined by measuring at least one of a gene copy number, a gene expression level, and a protein level.

20. The use of claim 12 wherein, the prediction of a treatment outcome is independent of a size of a primary tumor, a lymph node status, a grade, and a hormone receptor status.