Breast Cancer
Conditions
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
Interventions
RADIATIONNeoadjuvant 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.
Sponsors
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Hainan Medical University
Shandong Cancer Hospital and Institute
First Affiliated Hospital of Kunming Medical University
Chongqing University Cancer Hospital
Tangshan People's Hospital
Taizhou Hospital
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Chemotherapy combined with radiotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year EFS | 60 weeks | 5 years event-free survival after neoadjuvant chemoradiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| b-pCR | 18 weeks | Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0) |
| OS | 60 weeks | overall survival after completing of neoadjuvant chemoradiotherapy |
Countries
China
Contacts
Primary ContactZHENGJUN YANG, MD
Backup ContactQINGSONG PANG, MD
Outcome results
None listed