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Brief Title: A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
Official Title: A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer
Study ID: NCT03901469
Brief Summary: This is a two-part open label, non-randomized, Phase 2, study of ZEN003694 in combination with Talazoparib in patients with TNBC without germline mutations of BRCA1 or BRCA2. Part 1 is a dose escalation and Part 2 is a Simon 2-Stage design. There are 3 expansion cohorts: Expansion Cohort A (combination treatment in post-TROP2-ADC patients), Expansion Cohort B (ZEN003694 monotherapy), and Expansion Cohort C (combination treatment in TROP2-ADC-naive patients).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Tennessee Oncology (Sarah Cannon), Nashville, Tennessee, United States
MD Anderson, Houston, Texas, United States
Institut Jules Bordet, Anderlecht, , Belgium
UZ Leuven, Leuven, , Belgium
The First Affiliated Hosptial of Bengbu Medical College, Bengbu, Anhui, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Hunan Cancer Hospital, Changsha, Hunan, China
Affliated Hospital of Jining Medical University, Jining, Shandong, China
The Second People's Hospital of Neijiang, Neijiang, Sichuan, China
Tianjing Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, , Spain
START Madrid, Madrid, , Spain