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OncoMatch/Clinical Trials/NCT05659056

Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

Is NCT05659056 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pyrotinib, trastuzumab, paclitaxel-albumin for breast cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT05659056Data as of May 2026

Treatment: Pyrotinib, trastuzumab, paclitaxel-albuminBreast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (IHC 3+ or FISH+)

HER2 positive (HER2+++ by IHC or FISH+)

Disease stage

Required: Stage EARLY STAGE, III

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Kidney function

organs are functioning normally, like the renal function

Liver function

organs are functioning normally, like the liver function

Cardiac function

baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO

The organs are functioning normally, like the liver function, the renal function, and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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