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

Sponsor
Fudan University
Study ID
NCT04922008
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • capecitabine and trastuzumab — DRUG
    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.
  • vinorelbine and trastuzumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 10, 2021
Start date
Jul 1, 2021
Status verified
Jun 2021
Primary completion
Jun 30, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
356 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IRIS-C
  • Experimental: IRIS-D

Primary Outcome Measure

iDFS [ Time Frame: 5 years ]

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