OncoMatch/Clinical Trials/NCT04383275
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Is NCT04383275 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including capecitabine and trastuzumab and endocrine therapy and trastuzumab for breast cancer.
Treatment: capecitabine and trastuzumab · endocrine therapy and trastuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (IHC 3+ or IHC 0-2+ with FISH amplified)
HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified
Allowed: ESR1 expression ≥10%
HR positive (ER and/or PR ≥10%)
Allowed: PR (PGR) expression ≥10%
HR positive (ER and/or PR ≥10%)
Disease stage
Required: Stage I
Excluded: Stage IV
stage I breast cancer; Has metastic (Stage 4) breast cancer [excluded]
Demographics
Prior therapy
Cannot have received: neoadjuvant therapy
Lab requirements
Blood counts
hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 x 10^9 /L
Kidney function
serum creatinine ≤ 1×ULN and endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula)
Liver function
ALT ≤ 3×ULN, AST ≤ 3×ULN, TBIL ≤ 1.5×ULN
Cardiac function
LVEF >50%
adequate organ function ... hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 x 10^9 /L; ALT ≤ 3×ULN, AST ≤ 3×ULN, TBIL ≤ 1.5×ULN, serum creatinine ≤ 1×ULN and endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula); LVEF>50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04383275 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage I is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages