NCT03487666

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

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-21
• Primary completion: 2021-11-03
• Completion: 2024-05-02
• First posted: 2018-04-04
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study