Breast cancer prognostics

Abstract

The present invention provides new methods, uses and means for breast cancer prognostics. The provided method for establishing a prognosis for a mammalian subject having a breast cancer, comprises the steps of: obtaining a hormone receptor status of the subject; obtaining an HMGCR protein value of the subject; and correlating the hormone receptor status and the HMGCR protein of the subject to a prognosis for the subject.

1 .- 149 . (canceled) 
     
     
         150 . Method for determining a prognosis for a mammalian subject having a hormone receptor positive or a hormone receptor negative breast cancer, comprising the steps of:
 a) providing a sample earlier obtained from the subject;   b) evaluating the amount of HMGCR protein present in at least part of said sample, and determining a sample value corresponding to said evaluated amount;   c) comparing the sample value obtained in step b) with a reference value;   d) and, if said sample value is higher than said reference value:   d1) concluding that the prognosis for said subject is better than a first reference prognosis associated with the reference value if the subject has a hormone receptor positive breast cancer; or   d2) concluding that the prognosis for said subject is worse than a second reference prognosis associated with the reference value if the subject has a hormone receptor negative breast cancer.   
     
     
         151 . Method according to  claim 150 , further comprising the steps of:
 e) and, if said sample value is lower than, or equal to, said reference value,   e1) concluding that the prognosis for said subject is worse than, or equal to, the first reference prognosis associated with the reference value if the subject has a hormone receptor positive breast cancer; or   e2) concluding that the prognosis for said subject is better than, or equal to, the second reference prognosis associated with the reference value if the subject has a hormone receptor negative breast cancer.   
     
     
         152 . Method for determining whether a statin treatment is suitable for a mammalian subject having a hormone receptor negative breast cancer, comprising the steps of:
 a) providing a sample earlier obtained from the subject;   b) evaluating the amount of HMGCR protein present in at least part of said sample, and determining a sample value corresponding to said evaluated amount;   c) comparing the sample value obtained in step b) with a reference value; and, if said s ample value is equal to or lower than said reference value,   d) concluding that statin treatment is suitable for the subject.   
     
     
         153 . Method according to  claim 150 , wherein hormone receptor positive is estrogen receptor positive and/or progesterone receptor positive, and hormone receptor negative is estrogen receptor negative and progesterone receptor negative. 
     
     
         154 . Method according to  claim 150 , wherein hormone receptor positive is estrogen receptor positive, and hormone receptor negative is estrogen receptor negative. 
     
     
         155 . Method according to  claim 150 , wherein hormone receptor positive is progesterone receptor positive, and hormone receptor negative is progesterone receptor negative. 
     
     
         156 . Method according to  claim 150 , wherein said hormone receptor positive breast cancer is estrogen receptor positive. 
     
     
         157 . Method according to  claim 150 , wherein hormone receptor positive breast cancer is progesterone receptor positive. 
     
     
         158 . Method according to  claim 150 , wherein said hormone receptor negative cancer is further HER2 negative. 
     
     
         159 . Method according to  claim 150 , wherein said sample is a tissue sample. 
     
     
         160 . Method according to  claim 159 , wherein said tissue sample is a breast tumor sample. 
     
     
         161 . Method according to  claim 150 , wherein step b) comprises:
 b1) applying to the sample a quantifiable affinity ligand capable of selective interaction with the HMGCR protein to be evaluated, said application being performed under conditions that enable binding of the affinity ligand to any HMGCR protein present in the sample;   b2) removing non-bound affinity ligand; and   b3) quantifying any affinity ligand remaining in association with the sample to evaluate said amount.   
     
     
         162 . Method according to  claim 161 , wherein the quantifiable affinity ligand is selected from the group consisting of antibodies, fragments thereof and derivatives thereof. 
     
     
         163 . Kit for carrying out the method according to  claim 150 , which comprises
 a) a quantifiable affinity ligand capable of selective interaction with an HMGCR protein; and   b) reagents necessary for quantifying the amount of the affinity ligand.   
     
     
         164 . Kit according to  claim 163 , further comprising at least one reference sample for provision of a reference value. 
     
     
         165 . Kit according to  claim 163 , further comprising
 a′) a quantifiable affinity ligand capable of selective interaction with an estrogen receptor; and   b′) reagents necessary for quantifying the amount of the affinity ligand.   
     
     
         166 . Kit according to  claim 163 , further comprising
 a″) a quantifiable affinity ligand capable of selective interaction with a progesterone receptor; and   b″) reagents necessary for quantifying the amount of the affinity ligand.   
     
     
         167 . Kit according to  claim 163 , further comprising
 a′″) a quantifiable affinity ligand capable of selective interaction with a HER2 receptor; and   b′″) reagents necessary for quantifying the amount of the affinity ligand.   
     
     
         168 . Method for establishing a prognosis for a mammalian subject having a breast cancer, comprising the steps of:
 i) obtaining a hormone receptor status of the subject;   ii) obtaining an HMGCR protein value of the subject; and   iii) correlating the hormone receptor status and the HMGCR protein value of the subject to a prognosis for the subject.   
     
     
         169 . Method of treatment of a mammalian subject having a hormone receptor positive breast cancer, comprising the steps of:
 a) providing a sample from the subject;   b) evaluating the amount of HMGCR protein present in at least part of said sample, and determining a sample value corresponding to said evaluated amount;   c) comparing the sample value obtained in step b) with a reference value;   d) and if said sample value is equal to, or lower than, said reference value, treating said subject with an adjuvant breast cancer treatment.   
     
     
         170 . Method of treatment of a mammalian subject having a hormone receptor negative breast cancer, comprising the steps of:
 a) providing a sample from the subject;   b) evaluating the amount of HMGCR protein present in at least part of said sample, and determining a sample value corresponding to said evaluated amount;   c) comparing the sample value obtained in step b) with a reference value;   d) and if said sample value is higher than said reference value, treating said subject with an adjuvant breast cancer treatment.   
     
     
         171 . Method according to  claim 170 , wherein said adjuvant breast cancer treatment comprises statin therapy. 
     
     
         172 . Method according to  claim 171 , wherein said breast cancer is HER2 negative. 
     
     
         173 . Method according to  claim 169 , wherein the adjuvant breast cancer treatment is a radiotherapy, a chemotherapy, an endocrine treatment or a combination thereof, such as a sequential chemo-endocrine therapy.