Treatment of triple receptor negative breast cancer
View Patent ↗The present invention relates to the use of a liposomal preparation for the manufacture of a pharmaceutical composition and the use of such a composition for the treatment of ‘triple receptor negative’ breast cancer.
1. A method for treating triple negative breast cancer comprising administering a therapeutically effective amount of a combination of formulations, wherein the formulations include
(a) a formulation comprising a cationic liposomal preparation comprising at least one cationic lipid, a taxane, and optionally at least one neutral and/or anionic lipid; and
(b) a formulation comprising a non-liposomal preparation comprising taxane; and wherein the formulations are administered separately.
2. The method of claim 1 , wherein the formulations are administered sequentially.
3. The method of claim 1 , wherein the cationic liposomal preparation in the formulation of (a) comprises at least one cationic lipid from about 30 mol % to about 99.9 mole %, a taxane in an amount of at least about 0.1 mol % and optionally at least one neutral and/or anionic lipid from about 0 mole % to about 70 mole %.
4. The method of claim 1 , wherein the taxane is paclitaxel or a derivative thereof.
5. The method of claim 4 , wherein the cationic liposomal preparation in the formulation of (a) comprises paclitaxel in an amount of at least about 2 mole % to about 8 mole %, or at least 2.5 mole % to about 3.5 mole %.
6. The method of claim 1 , wherein the cationic liposomal preparation in the formulation of (a) has a zeta potential in the range of about +20 mV to 100 mV in about 0.05 mM KCl solution at about pH 7.5.
7. The method of claim 1 , wherein the cationic liposomal preparation in the formulation of (a) comprises DOTAP, DOPC, and paclitaxel.
8. The method of claim 1 , wherein the cationic liposomal preparation and the non-liposomal preparation are administered at different timepoints on the same day or on different days.
9. The method of claim 1 , wherein the cationic liposomal preparation is administered in a single dose between 1 mg/m 2 and 50 mg/m 2 per administration.
10. The method of claim 1 , wherein the cationic liposomal preparation is administered in a single dose between 20 mg/m 2 and 40 mg/m 2 per administration.
11. The method of claim 1 , wherein the cationic liposomal preparation is administered in a single dose of 22 mg/m 2 per administration.
12. The method of claim 1 , wherein the cationic liposomal preparation is administered in a single dose between 20 mg/m 2 and 50 mg/m 2 per administration and the non-liposomal preparation is administered in a single dose between 20 mg/m 2 and 100 mg/m 2 per administration.
13. The method of claim 1 , wherein the cationic liposomal preparation is administered in a single dose of 22 mg/m 2 per administration and the non-liposomal preparation is administered in a single dose of 70 mg/m 2 per administration.