Method of treating androgen receptor (AR)-positive breast cancers with selective androgen receptor modulator (SARMs)

1. A method of treating, inhibiting, or reducing the severity of ER-(+) AR-(+) metastatic breast cancer in a subject suffering from ER-(+) AR-(+) metastatic breast cancer, wherein said breast cancer has been previously treated with at least one prior hormone therapy, the method comprising administering to said subject a selective androgen receptor modulator (SARM) compound represented by a structure of Formula I:

X is O;

G is O;

T is OH, OR, —NHCOCH 3 , or NHCOR;

R is alkyl, dihaloalkyl, trihaloalkyl, CH 2 F, CHF 2 , CF 3 , CF 2 CF 3 , aryl, alkenyl or OH;

R 1 is CH 3 , CH 2 F, CHF 2 , CF 3 , CH 2 CH 3 , or CF 2 CF 3 ;

R 2 is H, F, Cl, Br, I, CH 3 , CF 3 , OH, CN, NO 2 , NHCOCH 3 , NHCOCF 3 , NHCOR, alkyl, arylalkyl, OR, NH 2 , NHR, N(R) 2 , or SR;

R 3 is H, F, Cl, Br, I, CN, NO 2 , COR, COOH, CONHR, CF 3 , or Sn(R) 3 ;

Z is NO 2 , CN, COR, COOH, or CONHR;

Y is CF 3 , F, Br, Cl, I, CN, or Sn(R) 3 ;

Q is CN, alkyl, halogen, N(R) 2 , NHCOCH 3 , NHCOCF 3 , NHCOR, NHCONHR, NHCOOR, OCONHR, CONHR, NHCSCH 3 , NHCSCF 3 , NHCSR, NHSO 2 CH 3 , NHSO 2 R, OR, COR, OCOR, OSO 2 R, SO 2 R or SR;

n is an integer of 1-4; and

m is an integer of 1-3; and

wherein said treating does not include preventing.

2. The method of claim 1 , comprising administering an isomer, a racemic mixture containing a SARM compound, a metabolite, pharmaceutically acceptable salt, pharmaceutical product, hydrate, N-oxide, or crystal of said selective androgen receptor modulator, or any combination thereof.

3. The method of claim 2 , wherein said administering comprises intravenously, intraarterially, or intramuscularly injecting to said subject said pharmaceutical product in liquid form; subcutaneously implanting in said subject a pellet containing said pharmaceutical product; orally administering to said subject said pharmaceutical product in a liquid or solid form; or topically applying to said subject said pharmaceutical product.

4. The method of claim 3 , wherein said pharmaceutical product is a pellet, a tablet, a capsule, a solution, a suspension, an emulsion, an elixir, a gel, a cream, a suppository or a parenteral formulation.

5. The method of claim 2 , wherein said pharmaceutical product comprises a 9 mg or an 18 mg dosage of said SARM compound.

6. The method of claim 1 , wherein said SARM compound is represented by a structure of Formula XIII:

or Formula XIV:

7. The method of claim 1 , wherein said SARM compound is represented by a structure of Formula II:

wherein X is O;

G is O;

T is OH, OR, —NHCOCH 3 , or NHCOR;

Z is NO 2 , CN, COR, COOH or CONHR;

Y is I, CF 3 , Br, Cl, or Sn(R) 3 ;

Q is CN, alkyl, halogen, N(R) 2 , NHCOCH 3 , NHCOCF 3 , NHCOR, NHCONHR, NHCOOR, OCONHR, CONHR, NHCSCH 3 , NHCSCF 3 , NHCSR, NHSO 2 CH 3 , NHSO 2 R, OR, COR, OCOR, OSO 2 R, SO 2 R or SR;

R is a C 1 -C 4 alkyl, aryl, phenyl, alkenyl, or hydroxyl and

R 1 is CH 3 , CF 3 , CH 2 CH 3 , or CF 2 CF 3 .

8. The method of claim 7 , comprising administering an isomer, a racemic mixture containing a SARM compound, a metabolite, pharmaceutically acceptable salt, pharmaceutical product, hydrate, N-oxide, or crystal of said selective androgen receptor modulator, or any combination thereof.

9. The method of claim 7 , wherein said SARM compound is represented by a structure of Formula:

10. The method of claim 1 , wherein said ER-(+) metastatic breast cancer is refractory.

11. The method of claim 1 , wherein said prior hormone therapy is a selective estrogen receptor modulator, aromatase inhibitor, and/or a selective estrogen receptor degrader.

12. The methods of claim 11 , wherein said selective estrogen receptor modulator, aromatase inhibitor, and/or selective estrogen receptor degrader is less than or equal to any three of tamoxifen, toremifene, letrozole, vorozole, fadrozole, anastrozole, exemestane, formestane, or fulvestrant.