OncoMatch/Clinical Trials/NCT04383275

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

Is NCT04383275 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including capecitabine and trastuzumab and endocrine therapy and trastuzumab for breast cancer.

Phase 2RecruitingFudan UniversityNCT04383275Data as of May 2026

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.

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Extracted eligibility criteria

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]

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

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.

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