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Trial Title:
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
NCT ID:
NCT06498154
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Chemotherapy combined with radiotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Masking Description
Intervention:
Intervention type:
Radiation
Intervention name:
Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
Description:
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.
Arm group label:
Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
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
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin medical university cancer institute and hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Xuchen Cao, MD
Phone:
8618622221160
Email:
caoxuchen@tmu.edu.cn
Start date:
July 15, 2024
Completion date:
June 30, 2032
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Hainan Medical University
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Tangshan People's Hospital
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498154
