drugset / Trial / NCT04383275

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

NCT04383275

Phase 2 Recruiting 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 or endocrine therapy in patients with HER-2 positive stage I breast cancer.

Timeline

Start
2021-08-23
Primary completion
2025-05-15
Completion
2027-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified
Subject Capecitabine Small molecule
Subject Exemestane Small molecule
Subject Letrozole Other / unclassified
Subject Tamoxifen Small molecule
Subject Toremifene Small molecule
Subject Trastuzumab Monoclonal antibody

Indications