Reduction of side effects from aromatase inhibitors used for treating breast cancer
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Publication Number
US-10765684-B2
Publication Date
2020-09-08
Expiration Date
Abstract
The present invention is directed generally to pharmaceutical compositions, methods, and kits for improving side effects associated with aromatase inhibitor treatment in a subject diagnosed with breast cancer. More specifically, the present invention provides compositions, methods, and kits comprising an aromatase inhibitor and an androgenic agent.
Core Innovation
The invention relates to reducing aromatase-inhibitor treatment side effects in post-menopausal breast cancer patients by administering an androgenic agent together with an aromatase inhibitor. The androgenic agent comprises testosterone or testosterone undecanoate, and the aromatase inhibitor is administered in an effective amount per day.
The invention addresses co-administration in postmenopausal patients being treated for breast cancer, where the aromatase inhibitor treatment is provided in an effective amount per day and the androgenic agent is provided in a daily amount of about 30–50 mg of testosterone or testosterone undecanoate. The described aromatase inhibitors include exemestane, anastrozole, and letrozole, with anastrozole indicated as preferred.
The disclosure includes treatment contexts and clinical findings that adding testosterone undecanoate to anastrozole maintains estrogen ablation while increasing testosterone, free testosterone, and dihydrotestosterone. The reported findings further indicate normalization of bone resorption markers and reductions in side effects including arthralgia, improvements in FACT-ES quality-of-life scores, and improved cognitive function.
Claims Coverage
The independent claim covers a method of mitigating one or more aromatase-inhibitor treatment side effects in a postmenopausal breast cancer patient by co-administering a specified daily amount of testosterone or testosterone undecanoate with an effective daily amount of an aromatase inhibitor; it specifically identifies urinary tract infection and breast pain as mitigated side effects. Dependent refinements emphasize administration route/formulation, specify anastrozole as an aromatase inhibitor (including a quantitative dose), and narrow the treatment context to adjuvant therapy after chemotherapy.
Testosterone or testosterone undecanoate with effective aromatase inhibitor for mitigating urinary tract infection or breast pain
Administering 30–50 mg per day of testosterone or testosterone undecanoate and an effective amount per day of an aromatase inhibitor to a postmenopausal patient being treated for breast cancer, wherein the mitigated one or more side effects comprises urinary tract infection or breast pain.
Oral administration of testosterone or testosterone undecanoate
The method includes orally administering testosterone or testosterone undecanoate in the co-administration regimen used to mitigate one or more side effects.
Specific testosterone daily dose within 30–50 mg/day
The method includes administering 30 mg per day of testosterone as part of the testosterone/testosterone undecanoate and aromatase inhibitor regimen for mitigating the specified side effects.
Anastrozole as the aromatase inhibitor
Using an aromatase inhibitor that is anastrozole for the co-administration regimen.
Anastrozole about 1 mg per day
Specifying that the aromatase inhibitor is anastrozole in an effective amount of about 1 mg per day.
Adjuvant therapy after prior chemotherapy
Specifying that the aromatase inhibitor treatment is given as adjuvant therapy to a patient who has already received chemotherapy.
Across the claim set, the core inventive coverage is co-administration of testosterone (or testosterone undecanoate) in a specified daily amount with an effective daily amount of an aromatase inhibitor to mitigate urinary tract infection or breast pain in postmenopausal breast cancer patients, with dependent features specifying oral delivery, particular dose constraints, anastrozole (including about 1 mg/day), and an adjuvant-after-chemotherapy context.
Stated Advantages
Normalization of bone resorption markers.
Reduced arthralgia.
Improved FACT-ES quality-of-life scores.
Improved cognitive function.
No major cholesterol concerns.
Maintains estrogen ablation while increasing testosterone/free testosterone and dihydrotestosterone.
Documented Applications
Reducing aromatase-inhibitor treatment side effects in post-menopausal breast cancer patients by co-administering testosterone or testosterone undecanoate with an aromatase inhibitor.
Use in a treatment context where the aromatase inhibitor is given as adjuvant therapy after the patient has already received chemotherapy.
Clinical evaluation showing testosterone undecanoate added to anastrozole maintains estrogen ablation while increasing testosterone measures and is associated with normalization of bone resorption markers, reduced arthralgia, improved FACT-ES quality-of-life scores, and improved cognitive function, with no major cholesterol concerns.
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