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Recruiting NCT06498154

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

Phase II Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS)

Overview

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.

Detailed description

The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome.

Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety

Interventions

  • Radiation Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
    Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) \* : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens.

Primary outcome measures

  • 5-year EFS [Time frame: 60 weeks]
Secondary outcome measures (2)
  • b-pCR [Time frame: 18 weeks]
  • OS [Time frame: 60 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin medical university cancer institute and hospital — Tianjin

Identifiers

NCT: NCT06498154 · TianJin Medical University....

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗