Spots Global Cancer Trial Database for Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
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Trial Identification
Brief Title: Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
Official Title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases
Study ID: NCT02258451
Conditions
Study Description
Brief Summary: The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, La Jolla, California, United States
, Los Angeles, California, United States
, New Haven, Connecticut, United States
, Hollywood, Florida, United States
, Ashland, Kentucky, United States
, Rockville, Maryland, United States
, Ann Arbor, Michigan, United States
, Detroit, Michigan, United States
, Pontiac, Michigan, United States
, Rochester, Minnesota, United States
, Saint Louis, Missouri, United States
, Newark, New Jersey, United States
, Jamaica, New York, United States
, Watertown, South Dakota, United States
, Spokane, Washington, United States
, Innsbruck, , Austria
, Bruxelles, , Belgium
, Edegem, , Belgium
, Kortrijk, , Belgium
, Leuven, , Belgium
, Angers Cedex, , France
, Nantes, , France
, NIMES Cedex 9, , France
, Saint-Cloud, , France
, Tours, , France
, Herne, Nordrhein-Westfalen, Germany
, Chai Wan, , Hong Kong
, Hong Kong, , Hong Kong
, Kowloon, , Hong Kong
, Afula, , Israel
, Beer Sheva, , Israel
, Haifa, , Israel
, Holon, , Israel
, Jerusalem, , Israel
, Jerusalem, , Israel
, Ramat Gan, , Israel
, Tel Aviv, , Israel
, Zrifin, , Israel
, Bologna, Emilia-Romagna, Italy
, Forlì Cesena, Emilia-Romagna, Italy
, Modena, Emilia-Romagna, Italy
, Roma, Lazio, Italy
, Roma, Lazio, Italy
, Genova, Liguria, Italy
, Cremona, Lombardia, Italy
, Milano, Lombardia, Italy
, Bari, Puglia, Italy
, Pisa, Toscana, Italy
, Nagoya, Aichi, Japan
, Sapporo, Hokkaido, Japan
, Osakasayama, Osaka, Japan
, Hidaka, Saitama, Japan
, Kita-Adachigun, Saitama, Japan
, Koto-ku, Tokyo, Japan
, Kagoshima, , Japan
, Osaka, , Japan
, Suwon-si, Gyeonggido, Korea, Republic of
, Seoul, Seoul Teugbyeolsi, Korea, Republic of
, Busan, , Korea, Republic of
, Daegu, , Korea, Republic of
, Incheon, , Korea, Republic of
, Seoul, , Korea, Republic of
, Oslo, , Norway
, Bialystok, , Poland
, Gdansk, , Poland
, Gdynia, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Singapore, , Singapore
, Singapore, , Singapore
, Singapore, , Singapore
, Palma de Mallorca, Illes Baleares, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Pamplona, , Spain
, Sevilla, , Spain
, Sevilla, , Spain
, Aarau, Aargau, Switzerland
, Kaohsiung City, , Taiwan
, Taichung, , Taiwan
, Taipei City, , Taiwan
, Taipei, , Taiwan
, Truro, Cornwall, United Kingdom
, Plymouth, Devon, United Kingdom
, Nottingham, Nottinghamshire, United Kingdom
, Taunton, Somerset, United Kingdom
, Bristol, , United Kingdom
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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