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

Primary Purpose

Breast Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

capecitabine and trastuzumab

endocrine therapy and trastuzumab

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IRIS-A

IRIS-B

Arm Description

Outcomes

Primary Outcome Measures

iDFS

invasive disease-free survival

Secondary Outcome Measures

DDFS

distant disease-free survival，

overall survival

Full Information

NCT ID

NCT04383275

First Posted

May 7, 2020

Last Updated

May 7, 2020

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04383275

Brief Title

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

Acronym

IRIS

Official Title

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

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 15, 2020 (Anticipated)

Primary Completion Date

May 15, 2025 (Anticipated)

Study Completion Date

May 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

356 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IRIS-A

Arm Type

Experimental

Arm Title

IRIS-B

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

capecitabine and trastuzumab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

endocrine therapy and trastuzumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

iDFS

Description

invasive disease-free survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

DDFS

Description

distant disease-free survival，

Time Frame

5 years

Title

Description

overall survival

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

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