Combination hormone replacement therapy (HRT) and melatonin to prevent and treat mammary cancer

• US 8,618,083 B2
• Filed: 07/20/2010
• Issued: 12/31/2013
• Est. Priority Date: 07/31/2009
• Status: Active Grant

• Current Assignee: Duquesne University of the Holy Spirit
• Original Assignee: Duquesne University of the Holy Spirit
• Inventors: Witt-Enderby, Paula A, Davis, Vicki L
• Primary Examiner(s): Anderson, James D
• Assistant Examiner(s): LEE, WILLIAM Y
• Application Number:
  US12/804,341
• Publication Number:
  US 20110028439A1
• Time in Patent Office: 1,260 Days
• Field of Search: None
• US Class Current: 514/170
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A combination hormone and melatonin therapy is provided to reduce the risk of developing, or to reduce the severity of, breast cancer by administering at least one estrogen hormone and optionally at least one progesterone-receptor-binding compound or composition and melatonin together, preferably at normal bed time.

Claims

1. A method of suppressing Her2+ mammary cancer tumor development in a patient in need of said suppression, comprising administering in unit dosage form an estrogen, a progesterone-receptor-binding compound or composition, and melatonin, wherein said melatonin is administered to correspond with the sleep cycle of said patient and wherein said estrogen is 17β

-estradiol, said progesteron-receptor-binding compound or composition is progesterone, and where said 17β

-estradiol is administered via oral route of administration to said patient in the amount of 0.1-0.9 mg per day, said progesterone is administered via oral route of administration to said patient in the amount of 10-90 mg per day and further wherein said melatonin is administered via oral route of administration in a dose of between 1-9 mg per day.