Spots Global Cancer Trial Database for Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
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Trial Identification
Brief Title: Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official Title: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
Study ID: NCT04958785
Conditions
Study Description
Brief Summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with nab-paclitaxel or paclitaxel (cohort 1) or with sacituzumab govitecan-hziy (cohort 2) in patients with non-surgically removable locally advanced or metastatic triple-negative breast cancer.
Detailed Description: The primary objective of this study for the safety run-in cohorts of the study is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC). The primary objective of this study for Phase 2 Cohort 1 is to compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone, as determined by progression-free survival (PFS) by investigator assessment. The primary objective of this study for Phase 2 Cohort 2 is to evaluate the efficacy of magrolimab in combination with sacituzumab govitecan as determined by confirmed objective response rate (ORR) by investigator assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
Women's Cancer Care, Fresno, California, United States
Providence Medical Foundation, Fullerton, California, United States
University of California San Francisco, San Francisco, California, United States
Saint John's Cancer Institute, Santa Monica, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Mayo Clinic, Jacksonville, Florida, United States
University Cancer & Blood Center,LLC, Athens, Georgia, United States
Winship Cancer Institute Emory University, Atlanta, Georgia, United States
Southeastern Regional Medical Center, LLC, Newnan, Georgia, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Allina Health Cancer Institute, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
Charleston Oncology, Charleston, South Carolina, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, Australia
University of the Sunshine Coast, Sippy Downs, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Cancer Research SA, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Peninsula Health, Frankston, Victoria, Australia
Barwon Health- University Hospital Geelong, Geelong, Victoria, Australia
Ballarat Oncology & Haematology Services, Wendouree, Victoria, Australia
Queen Mary Hospital, Hong Kong, , Hong Kong
Princess Margaret Hospital, Kowloon, , Hong Kong
Prince of Wales Hospital, New Territories, , Hong Kong
Samsung Medical Center, Gangnam-Gu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Jongrogu, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Taipei Veterans General Hospital, Beitou District, , Taiwan
Changhua Christian Hospital, Changhua City, , Taiwan
Chang Gung Memorial Hospital, Linkou, Guishan District, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Sanmin District, , Taiwan
National Taiwan University Hospital, Tapiei, , Taiwan
University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
University College London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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