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OncoMatch/Clinical Trials/NCT06498154

Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy

Is NCT06498154 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.

Phase 2RecruitingTianjin Medical University Cancer Institute and HospitalNCT06498154Data as of May 2026

Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and ISH positive)

HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive)

Required: ESR1 negative (negative)

HR negative HER2 IHC score of 3+, or 2+and ISH test positive

Required: PR (PGR) negative (negative)

HR negative HER2 IHC score of 3+, or 2+and ISH test positive

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: any medication in this study

Has used any medication in this study within 14 days prior to enrollment

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L; PLT ≥ 90 × 10^9/L; Hb ≥ 90 g/L

Kidney function

BUN and Cr ≤ 1.5 × ULN

Liver function

TBIL ≤ 2.5 × ULN; ALT and AST ≤ 2.5 × ULN

Cardiac function

LVEF ≥ 50%; QTcF < 470 ms (females)

LVEF ≥ 50%; 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms; blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN#

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

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