US 2025/0367252 A1 · GOSERELIN IMPLANT DOSING REGIMENS FOR IMPROVED PATIENT COMPLIANCE

Abstract

Described herein are methods of improving duration of ovarian function suppression in a patient with hormone receptor positive breast cancer which include administering a plurality of 3.6 mg goserelin acetate implant doses to the patient administered once every 4 weeks. After the plurality of 3.6 mg goserelin acetate implant doses are administered, adverse events, breakthrough menses, estradiol elevation, or a combination thereof are asssessed in the patient. Upon determining mild adverse events, absence of breakthrough menses, absence of estradiol elevation, or a combination thereof, the 3.6 mg goserelin acetate implant is discontinued and a plurality of 10.8 mg goserelin implant doses once every 12 weeks are administered. The duration of treatment of the patient with the 3.6 mg goserelin acetate implant and the 10.8 mg goserelin implant is greater than two years to the lifetime of the patient.

Claims24

Dependent claims

A method of improving duration of ovarian function suppression in a patient with hormone receptor positive breast cancer comprising

administering a plurality of 3.6 mg goserelin acetate implant doses to the patient, wherein the 3.6 mg goserelin acetate implant doses are prescribed to be administered once every 4 weeks, wherein the plurality of 3.6 mg goserelin acetate implant doses is three to twelve doses,
after the plurality of 3.6 mg goserelin acetate implant doses are administered, assessing adverse events, breakthrough menses, estradiol elevation, or a combination thereof in the patient, and
upon determining mild adverse events, absence of breakthrough menses, absence of estradiol elevation, or a combination thereof, discontinuing the 3.6 mg goserelin acetate implant, and
administering a plurality of 10.8 mg goserelin implant doses to the patient, wherein the 10.8 mg goserelin implant is prescribed to be administered once every 12 weeks,
wherein the duration of treatment of the patient with the 3.6 mg goserelin acetate implant doses and the 10.8 mg goserelin implant doses is greater than two years to the lifetime of the patient.

2 more elements

A method of ovarian function suppression treatment in a patient with hormone receptor positive breast cancer comprising

administering a first plurality of 3.6 mg goserelin acetate implant doses to the patient, wherein the first plurality of 3.6 mg goserelin acetate implant doses are prescribed to be administered once every 4 weeks, wherein the first plurality of 3.6 mg goserelin acetate implant doses is three to twelve doses,
after the first plurality of the goserelin acetate implant doses are administered, assessing adverse events, breakthrough menses, estradiol elevation, or a combination thereof in the patient, and
upon determining moderate adverse events, breakthrough menses, estradiol elevation, or a combination thereof, administering a second plurality of 3.6 mg goserelin acetate implant doses, wherein the second plurality of 3.6 mg goserelin acetate implant doses are prescribed to be administered once every 4 weeks.

Dependencies are inferred from the claim text.

Goserelin implant dosing regimens for improved patient compliance

Life of this patent

Goserelin implant dosing regimens for improved patient compliance

Life of this patent

Abstract

Claims24