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Brief Title: Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Official Title: A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)
Study ID: NCT01446159
Brief Summary: Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
Detailed Description: This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Scottsdale, Arizona, United States
Research Site, Bakersfield, California, United States
Research Site, Pleasant Hill, California, United States
Research Site, Stamford, Connecticut, United States
Research Site, Fort Myers, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Port Saint Lucie, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Athens, Georgia, United States
Research Site, Augusta, Georgia, United States
Research Site, Lawrenceville, Georgia, United States
Research Site, Scarborough, Maine, United States
Research Site, Baltimore, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Bethesda, Maryland, United States
Research Site, Frederick, Maryland, United States
Research Site, Rockville, Maryland, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Lansing, Michigan, United States
Research Site, Rochester, Minnesota, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Lake Success, New York, United States
Research Site, Lake Success, New York, United States
Research Site, Canton, Ohio, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Middletown, Ohio, United States
Research Site, Toledo, Ohio, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Houston, Texas, United States
Research Site, Lubbock, Texas, United States
Research Site, Richmond, Virginia, United States
Research Site, Nassau, , Bahamas
Research Site, Aalst, , Belgium
Research Site, Brasschaat, , Belgium
Research Site, Brugge, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Edegem, , Belgium
Research Site, Leuven, , Belgium
Research Site, Mons, , Belgium
Research Site, Oshawa, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Le Mans, , France
Research Site, Montpellier, , France
Research Site, Dortmund, , Germany
Research Site, Frankfurt, , Germany
Research Site, Muenchen, , Germany
Research Site, Witten, , Germany
Research Site, Miskolc, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Haifa, , Israel
Research Site, Petach Tikva, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Rechovot, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Zerifin, , Israel
Research Site, Lodz, , Poland
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Malaga, , Spain
Research Site, Cardiff., , United Kingdom
Research Site, London, , United Kingdom
Research Site, Southampton, , United Kingdom
Research Site, Stoke-on-Trent, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Name: MedImmune LLC
Affiliation: MedImmune LLC
Role: STUDY_DIRECTOR