Spots Global Cancer Trial Database for Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
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Trial Identification
Brief Title: Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Official Title: A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Study ID: NCT03250676
Interventions
Study Description
Brief Summary: The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene \[ESR1\] Y537S mutation).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix, Goodyear, Arizona, United States
University of California Los Angeles, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
University of Colorado - Cancer Center, Aurora, Colorado, United States
Holy Cross Hospital Inc, Fort Lauderdale, Florida, United States
Florida Cancer Specialists South, Fort Myers, Florida, United States
Florida Cancer Specialists North, Saint Petersburg, Florida, United States
Florida Cancer Specialists and Research Institute, Sarasota, Florida, United States
Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta, Newnan, Georgia, United States
Carle Cancer Center, Urbana, Illinois, United States
Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago, Zion, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Tennessee Oncology, Nashville, Tennessee, United States
Parkland Health and Hospital System, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Tyler Oncology/Oncology PA, Tyler, Texas, United States
Huntsman Cancer Institute at The University of Utah, Salt Lake City, Utah, United States
Edog - Ico - Ppds, Angers, , France
Hopital Jean Minjoz, Besançon, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Oscar Lambret, Lille, , France
Hôpital Saint Louis, Paris, , France
Hôpital de la Pitié Salpétrière, Paris, , France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS, Rennes, , France
EDOG Institut de Cancerologie de l'Ouest - PPDS, St. Herblain, , France
Institut de Cancérologie Strasbourg Europe, Strasbourg, , France
Institut Gustave Roussy, Villejuif Cedex, , France
The Royal Marsden NHS Foundation Trust, Chelsea, London, United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
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