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

Recruiting now · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06498154

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

200

Starts

2024-07-25

Expected to finish

2032-06-30

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
• ECOG score 0-1
• Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
• Left ventricular ejection fraction (LVEF) ≥ 50%
• 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms
• The functional level of the main organs must meet the following requirements: 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#
• For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
• Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.

You may not qualify if…

• Inflammatory breast cancer
• Metastatic tumor
• Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol.
• Active infections that require systemic treatment
• Has used any medication in this study within 14 days prior to enrollment
• Major surgery (excluding biopsy) performed within 14 days before enrollment

Where it is running

• Tianjin medical university cancer institute and hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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