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Brief Title: A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Official Title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole
Study ID: NCT04075604
Brief Summary: A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0031, Whittier, California, United States
University Cancer Blood Ctr, Athens, Georgia, United States
Northside Hospital,Inc.- Central Research Department, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Local Institution - 0041, Florham Park, New Jersey, United States
The Cancer Center At Hackensack University Medical Center, Hackensack, New Jersey, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Hematology-Oncology Associates Of Fredricksburg, Inc, Fredericksburg, Virginia, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Local Institution - 0005, Elizabeth Vale, South Australia, Australia
Breast Cancer Research Centre - WA, Nedlands, Western Australia, Australia
Local Institution - 0011, Wilrijk, Antwerpen, Belgium
Local Institution, Liege, , Belgium
Local Institution, Namur, , Belgium
Local Institution - 0071, Ottawa, Ontario, Canada
Local Institution - 0075, Bordeaux, , France
Local Institution - 0073, Creteil Cedex, , France
Local Institution - 0072, La Roche-sur-yon Cedex 9, , France
Centre Leon Berard, Lyon Cedex 08, , France
Local Institution - 0019, Marseille Cedex 9, , France
Centre de Cancerologie du Grand Montpellier, Montpellier, , France
Institut Claudius Regaud, TOULOUSE Cedex 9, , France
Local Institution, Bonn, , Germany
Local Institution, Erlangen, , Germany
Klinik Essen-Mitte, Essen, , Germany
Local Institution, Moenchengladbach, , Germany
Local Institution, Saarbruecken, , Germany
Local Institution - 0047, Monterrey Ponce, , Puerto Rico
Local Institution - 0002, San Juan, , Puerto Rico
Local Institution - 0062, San Juan, , Puerto Rico
H. Univ. Vall dHebron, Barcelona, , Spain
Local Institution - 0037, Barcelona, , Spain
Hosp Univer 12 De Octubre, Madrid, , Spain
Hospital Universitario Virgen De La Victoria, Malaga, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Clinico Universitario De Valencia, Valencia, , Spain
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR