Combinations of a mithramycin analogue and another chemotherapeutic agent for the treatment of triple negative breast cancer

1. A composition comprising:

a) a compound of Formula (I),

 or a salt, co-crystal or solvate thereof; and

b) at least one chemotherapeutic agent, or a salt, co-crystal or solvate thereof, wherein said at least one chemotherapeutic agent is:

i) the anti-mitotic chemotherapeutic agent, docetaxel, wherein the molar ratio of the compound of the Formula (I) to said anti-mitotic chemotherapeutic agent is from 1:0.05 to 1:1;

ii) the nucleoside analog chemotherapeutic agent, gemcitabine, wherein the molar ratio of the compound of the Formula (I) to said nucleoside analog chemotherapeutic agent is from 1:0.1 to 1:2;

iii) the tyrosine kinase inhibitor, dasatinib, wherein the molar ratio of the compound of the Formula (I) to said tyrosine kinase inhibitor is from 1:0.1 to 1:2; and/or

iv) vinorelbine, wherein the molar ratio of the compound of the Formula (I) to vinorelbine is 1:0.3.

2. A composition according to claim 1 , wherein the at least one chemotherapeutic agent is the anti-mitotic chemotherapeutic agent docetaxel.

3. A composition according to claim 1 , wherein the at least one chemotherapeutic agent is the nucleoside analog chemotherapeutic agent gemcitabine.

4. A composition according to claim 1 , wherein the at least one chemotherapeutic agent is the tyrosine kinase inhibitor dasatinib.

5. A kit-of-parts for use in treating triple negative breast cancer comprising:

a) a compound of Formula (I),

 or a salt, co-crystal or solvate thereof; and

b) at least one chemotherapeutic agent, or a salt, co-crystal or solvate thereof, wherein said at least one chemotherapeutic agent is:

i) the anti-mitotic chemotherapeutic agent, docetaxel, wherein the molar ratio of the compound of the Formula (I) to said anti-mitotic chemotherapeutic agent is from 1:0.05 to 1:1;

ii) the nucleoside analog chemotherapeutic agent, gemcitabine, wherein the molar ratio of the compound of the Formula (I) to said nucleoside analog chemotherapeutic agent is from 1:0.1 to 1:2;

iii) the tyrosine kinase inhibitor, dasatinib, wherein the molar ratio of the compound of the Formula (I) to said tyrosine kinase inhibitor is from 1:0.1 to 1:2; and/or

iv) vinorelbine, wherein the molar ratio of the compound of the Formula (I) to vinorelbine is 1:0.3.

6. A method for producing a composition according to claim 1 , which comprises mixing:

a) a compound of Formula (I),

 or a salt, co-crystal or solvate thereof; and

b) at least one chemotherapeutic agent, or a salt, co-crystal or solvate thereof, wherein said at least one chemotherapeutic agent is:

i) the anti-mitotic chemotherapeutic agent, docetaxel, wherein the molar ratio of the compound of the Formula (I) to said anti-mitotic chemotherapeutic agent is from 1:0.05 to 1:1;

ii) the nucleoside analog chemotherapeutic agent, gemcitabine, wherein the molar ratio of the compound of the Formula (I) to said nucleoside analog chemotherapeutic agent is from 1:0.1 to 1:2;

iii) the tyrosine kinase inhibitor, dasatinib, wherein the molar ratio of the compound of the Formula (I) to said tyrosine kinase inhibitor is from 1:0.1 to 1:2; and/or

iv) vinorelbine, wherein the molar ratio of the compound of the Formula (I) to vinorelbine is 1:0.3.

7. A method of preventing and/or treating breast cancer by administering to a patient a composition according to claim 1 .

8. A method of treating triple negative breast cancer by administering to a subject in need thereof: a compound of Formula (I),

or a salt, co-crystal or solvate thereof; and

at least one chemotherapeutic agent, or a salt, co-crystal or solvate thereof, wherein said at least one chemotherapeutic agent is:

i) the anti-mitotic chemotherapeutic agent, docetaxel, wherein the molar ratio of the compound of the Formula (I) to said anti-mitotic chemotherapeutic agent is from 1:0.05 to 1:1;

ii) the nucleoside analog chemotherapeutic agent, gemcitabine, wherein the molar ratio of the compound of the Formula (I) to said nucleoside analog chemotherapeutic agent is from 1:0.1 to 1:2;

iii) the tyrosine kinase inhibitor, dasatinib, wherein the molar ratio of the compound of the Formula (I) to said tyrosine kinase inhibitor is from 1:0.1 to 1:2; and/or

iv) vinorelbine, wherein the molar ratio of the compound of the Formula (I) to vinorelbine is 1:0.3,

wherein said compound of Formula (I), or a salt, co-crystal or solvate thereof, and said at least one chemotherapeutic agent, or a salt, co-crystal or solvate thereof are administered simultaneously, separately or sequentially from each other.