drugset / Trial / NCT04922008

Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS-C/D)

NCT04922008 ↗

Phase 2 Unknown 356 enrolled Fudan University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy (capecitabine or vinorelbine) in patients with HER-2 positive stage I breast cancer.

Timeline

Start
2021-07-01
Primary completion
2024-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — Oral
Subject Vinorelbine Small molecule — Oral
Background Trastuzumab Monoclonal antibody — —

Indications