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

PHASE2RecruitingINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

August 23, 2021

Primary Completion Date

May 15, 2025

Study Completion Date

May 15, 2027

Conditions
Breast Cancer
Interventions
DRUG

capecitabine and trastuzumab

In IRIS-A cohort, patients who met the inclusion criteria(ER,PR\<10%, T≤2cm or ER,PR ≥10% 1cm\<T≤2cm)would be given capecitabine for 6 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.

DRUG

endocrine therapy and trastuzumab

In IRIS-B cohort, patients who met the inclusion criteria(ER,PR ≥10% T≤1cm) would be given endocrine therapy (premenopausal: tamoxifen or toremifene; postmenopausal: letrozole or anastrozole or exemestane) combined with standard trastuzumab for 1 year and complete endocrine therapy for 5 years.

Trial Locations (1)

200032

RECRUITING

Breast cancer institute of Fudan University Cancer Hospital, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER