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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT03487666
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This pilot study will provide preliminary data regarding the role of PIS in predicting the benefit of immune checkpoint inhibition with or without chemotherapy for high risk patients with TNBC and residual disease after effective neoadjuvant chemotherapy.

Key Dates

Start date
May 21, 2018
Status verified
Nov 2024
Primary completion
Nov 3, 2021
Completion
May 2, 2024

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Nivolumab 360 mg iv q3weeks for x 6 cycles
  • Active Comparator: Arm B
    Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
  • Experimental: Arm C
    Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles

Primary Outcome Measure

Percent Change in the Peripheral Immunoscore (PIS) at Week 6 [ Time Frame: 6 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
University of ChicagoChicagoIllinois60637-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MedStar Georgetown University Hospital· Washington D.C., DCMedStar Washington Hospital Center· Washington D.C., DCUniversity of Chicago· Chicago, ILJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

Related Studies