Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Keywords
Abstract
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.
Dates
Last Verified: | 04/30/2020 |
First Submitted: | 05/06/2020 |
Estimated Enrollment Submitted: | 05/06/2020 |
First Posted: | 05/11/2020 |
Last Update Submitted: | 05/06/2020 |
Last Update Posted: | 05/11/2020 |
Actual Study Start Date: | 05/14/2020 |
Estimated Primary Completion Date: | 05/14/2025 |
Estimated Study Completion Date: | 05/14/2027 |
Condition or disease
Intervention/treatment
Drug: IRIS-A
Drug: IRIS-B
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: IRIS-A | Drug: IRIS-A 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. |
Experimental: IRIS-B | Drug: IRIS-B 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
Criteria | 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. |
Outcome
Primary Outcome Measures
1. iDFS [5 years]
Secondary Outcome Measures
1. DDFS [5 years]
2. OS [5 years]