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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2026

Conditions
Breast Cancer
Interventions
DRUG

capecitabine and trastuzumab

In IRIS-C cohort, patients who met the inclusion criteria(ER and PR\<10%, T≤2cm or ER and/or PR ≥10% 1cm\<T≤2cm) would be given capecitabine for 4 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.

DRUG

vinorelbine and trastuzumab

In IRIS-4 cohort, patients who met the inclusion criteria(ER and PR\<10%, T≤2cm or ER and/or PR ≥10% 1cm\<T≤2cm) would be given vinorelbine for 4 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.

All Listed Sponsors
lead

Fudan University

OTHER