Compositions, kits, and methods for identification, assessment, prevention, and therapy of breast cancer
View Patent ↗The invention relates to compositions, kits, and methods for detecting, characterizing, preventing, and treating human breast cancers. A variety of newly identified markers are provided, wherein changes in the levels of expression of one or more of the markers is correlated with the presence of breast cancer.
1. A method of assessing whether a patient is afflicted with breast cancer, the method comprising comparing:
(a) the level of expression of the marker consisting of SEQ ID NO:2 in a patient sample; and
(b) the level of expression of the marker consisting of SEQ ID NO:2 in a control non-breast cancer sample,
wherein the patient sample is a breast associated body fluid, a breast tissue or a portion of a breast tissue,
wherein an increase in the level of expression of the marker consisting of SEQ ID NO:2 in the patient sample as compared to the level of expression of the marker consisting of SEQ ID NO:2 in the control sample is an indication that the patient is afflicted with breast cancer, thereby assessing whether a patient is afflicted with breast cancer.
2. A method of assessing whether a patient is afflicted with estrogen receptor negative breast cancer, the method comprising comparing:
(a) the level of expression of the marker consisting of SEQ ID NO:2 in a patient sample; and
(b) the level of expression of the marker consisting of SEQ ID NO:2 in an estrogen receptor (ER) positive breast cancer sample,
wherein the patient sample is a breast associated body fluid, a breast tissue or a portion of a breast tissue,
wherein a difference between the level of expression of the marker consisting of SEQ ID NO:2 in the patient sample as compared to the level of expression of the marker consisting of SEQ ID NO:2 in the ER positive breast cancer sample is an indication that the patient is afflicted with estrogen receptor negative breast cancer, thereby assessing whether a patient is afflicted with estrogen receptor negative breast cancer.
3. The method of claim 1 , wherein the marker is detected using an antibody or antigen binding fragment thereof which specifically binds the marker.
4. The method of claim 3 , wherein the antibody or fragment thereof is a monoclonal antibody or a fragment thereof.
5. The method of claim 3 , wherein the antibody or fragment thereof is a polyclonal antibody or a fragment thereof.
6. The method of claim 3 , wherein the antibody or a fragment thereof is labeled.
7. The method of claim 6 , wherein the antibody or fragment thereof is radio-labeled.
8. The method of claim 6 , wherein the antibody or fragment thereof is biotin-labeled.
9. The method of claim 6 , wherein the antibody or fragment thereof is labeled with a label selected from the group consisting of a chromophore label, a fluorophore label, and an enzyme label.
10. The method of claim 1 , wherein the level of expression of the marker consisting of SEQ ID NO:2 in the patient sample differs from the level of expression of the marker consisting of SEQ ID NO:2 in the control sample by a factor of at least about 2.
11. The method of claim 1 , wherein the level of expression of the marker consisting of SEQ ID NO:2 in the patient sample differs from the level of expression of the marker consisting of SEQ ID NO:2 the control sample by a factor of at least about 5.
12. The method of claim 1 , wherein the patient sample is a breast-associated body fluid.
13. The method of claim 12 , wherein the breast-associated body fluid is selected from the group consisting of blood, breast fluid, lymph fluid, cystic fluid, nipple aspirates, and fluid collected from a lump biopsy.
14. The method of claim 1 , wherein the patient sample comprises cells obtained from a breast tissue sample.
15. A method of assessing whether a patient is afflicted with estrogen receptor negative breast cancer, the method comprising comparing:
(a) the level of expression of the marker of SEQ ID NO:2 in a patient sample; and
(b) the level of expression of the marker of SEQ ID NO:2 in an estrogen receptor (ER) positive breast cancer sample,
wherein the patient sample is a breast associated body fluid, a breast tissue or a portion of a breast tissue,
wherein an increase in the level of expression of the marker of SEQ ID NO:2 in the patient sample as compared to the level of expression of the marker of SEQ ID NO:2 in the ER positive breast cancer sample is an indication that the patient is afflicted with estrogen receptor negative breast cancer, thereby assessing whether a patient is afflicted with estrogen receptor negative breast cancer.