OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 21, 2018

Primary Completion Date

November 3, 2021

Study Completion Date

May 2, 2024

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Nivolumab

Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.

DRUG

Capecitabine

Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects

Trial Locations (4)

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

MedStar Washington Hospital Center, Washington D.C.

60637

University of Chicago, Chicago

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Georgetown University

OTHER