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

NCT04922008 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2021-06-10

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-06-30
Completion
2026-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922008 on ClinicalTrials.gov