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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2025

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.

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.

Arms, Groups and Cohorts

  • Experimental: IRIS-A
  • Experimental: IRIS-B

Clinical Trial Outcome Measures

Primary Measures

  • iDFS
    • Time Frame: 5 years
    • invasive disease-free survival

Secondary Measures

  • DDFS
    • Time Frame: 5 years
    • distant disease-free survival,
  • OS
    • Time Frame: 5 years
    • overall survival

Participating in This Clinical Trial

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. 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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhimin Shao, Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery – Fudan University
  • Overall Contact(s)
    • Zhimin Shao, MD, +86-021-64175590, zhimingshao@yahoo.com

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