Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 24, 2021

Primary Completion Date

October 24, 2024

Study Completion Date

December 2, 2024

Conditions
Breast CancerTriple Negative Breast Cancer
Interventions
DRUG

Capecitabine

Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles

DRUG

Talazoparib

Talazoparib Cycle 1: 0.75 mg then Cycle 2-8: 1 mg Cycle = 21 days; Total of 8 cycles

DRUG

Pembrolizumab

Per standard of care.

DRUG

Inavolisib

Inavolisib Cycle 1: 6 mg then Cycle 2-8: 9mg Orally 21 days on Cycle = 21 days; Total of 8 cycles

Trial Locations (13)

20057

Georgetown University, Washington D.C.

27103

Novant Health Cancer Institute, Winston-Salem

33028

Memorial Healthcare System, Hollywood

33176

Miami Cancer Institute at Baptist Health, Inc., Miami

35294

University of Alabama at Birmingham, Birmingham

46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

Advocate Aurora Research Institute (Illinois), Wauwatosa

Aurora Health Care, Wauwatosa

53705

University of Wisconsin, Madison

60637

University of Chicago Medical Center, Chicago

78229

Mays Cancer Center at UT Health San Antonio, San Antonio

07922

Summit Health, Berkeley Heights

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Foundation Medicine

INDUSTRY

collaborator

Indiana University

OTHER

collaborator

Vera Bradley Foundation for Breast Cancer

OTHER

lead

Bryan Schneider, MD

OTHER