Clinical trial NCT06498154: Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of Hainan Medical University
name: Shandong Cancer Hospital and Institute
name: First Affiliated Hospital of Kunming Medical University
name: Chongqing University Cancer Hospital
name: Tangshan People's Hospital
name: Taizhou Hospital
First posted: 2024-07-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Chemotherapy combined with radiotherapy
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: 5-year EFS
timeFrame: 60 weeks
Secondary outcomes:
measure: b-pCR
timeFrame: 18 weeks
measure: OS
timeFrame: 60 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university cancer institute and hospital
Study officials:
affiliation: TianJin Medical University Cancer Institute and Hospitall
name: XUCHEN CAO, MD
role: PRINCIPAL_INVESTIGATOR
References: