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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine and trastuzumab; Drug: endocrine therapy and trastuzumab

• Registration Number: NCT04383275
• Lead Sponsor: Fudan University

Brief Summary

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy or endocrine therapy in patients with HER-2 positive stage I breast cancer.

Detailed Description

This study has two cohorts. In Cohort A, 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. In Cohort B, 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2021-08-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-05-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 356

Inclusion Criteria

• Females 18-70 years old;
• Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the lymph node is negative (N0);
• In IRIS-A cohort, if a patient is HR negative(ER/PR<10%), the longest diameter of invasive cancer could not exceed 2cm; while if a patient is HR positive(ER and/or PR ≥10%）,the longest diameter of invasive cancer is greater than 1cm and no more than 2cm;
• In IRIS-B cohort, a patient need to be HR positive (ER and / or PR expression ≥10%) and the longest diameter of invasive cancer could not exceed 1cm;
• The pathological type of immunohistochemistry must meet the following conditions: HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;
• For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled;
• Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);
• LVEF>50%;
• The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

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Exclusion Criteria

• Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;
• Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;
• Has metastic (Stage 4) breast cancer;
• Pregnant or breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
• Patients participating in other clinical trials at the same time;
• Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
• Has severe or uncontrolled infection;
• Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
• The researchers considered patients to be unsuitable for the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRIS-A	capecitabine and trastuzumab	-
IRIS-B	endocrine therapy and trastuzumab	-

Primary Outcome Measures

Name	Time	Method
iDFS	5 years	invasive disease-free survival

Secondary Outcome Measures

Name	Time	Method
OS	5 years	overall survival
DDFS	5 years	distant disease-free survival，

Trial Locations

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China