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

Fudan University1 site in 1 country356 target enrollmentAugust 23, 2021

ConditionsBreast Cancer

Interventionscapecitabine and trastuzumab endocrine therapy and trastuzumab

Drugscapecitabine and trastuzumab endocrine therapy and trastuzumab

Overview

Phase: Phase 2
Intervention: capecitabine and trastuzumab
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 356
Locations: 1
Primary Endpoint: iDFS
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 23, 2021

End Date

May 15, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhimin Shao

Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery

Fudan University

Eligibility 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.