Actively Recruiting
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Led by Fudan University · Updated on 2024-03-22
356
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Pathologically confirmed stage I breast cancer with invasive tumor diameter no more than 2 cm and negative lymph nodes
- For Cohort A: Hormone receptor negative (ER, PR <10%) with tumor ≤ 2 cm, or hormone receptor positive (ER and/or PR ≥10%) with tumor >1 cm but ≤ 2 cm
- For Cohort B: Hormone receptor positive (ER and/or PR ≥10%) with tumor ≤ 1 cm
- HER-2 positive by immunohistochemistry (3+) or FISH amplification if 0-2+
- Patients with invasive lesions on both breasts can participate if both lesions are HER-2 positive and meet size requirements
- Adequate organ function including bone marrow, liver, kidney function, and LVEF >50%
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Prior neoadjuvant therapy including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy
- History of other malignancies except treated basal cell carcinoma or cervical carcinoma in situ
- Metastatic (stage 4) breast cancer
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception
- Concurrent participation in other clinical trials
- Severe organ dysfunction or LVEF <50%, or recent severe cardiovascular disease
- Poorly controlled diabetes or severe hypertension
- Severe or uncontrolled infections
- History of substance abuse or mental disorders preventing compliance
- Considered unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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