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

Breast Cancer Clinical Trial

Official title:

An Open-label, Phase II Study Evaluating the Efficacy and Safety of Trastuzumab Combined With Oral Chemotherapy in Patients With HER-2 Positive Stage I Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04922008
• Other study ID #: SCHBCC-N034
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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);
• 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;
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iDFS	iDFS invasive disease-free survival	5 years
Secondary	DDFS	distant disease-free survival	5 years
Secondary	OS	overall survival	5 years