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

Sponsor
Fudan University
Study ID
NCT04922008
Phase
PHASE2
Status
Not Yet Recruiting

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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

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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