A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
NCT ID: NCT06769919
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
340 participants
INTERVENTIONAL
2024-12-31
2031-12-31
Brief Summary
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Detailed Description
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After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.
Primary Endpoint:
Residual Cancer Burden (RCB) 0/I.
Secondary Endpoints:
Event-Free Survival (EFS) Invasive Disease-Free Survival (iDFS) Overall Survival (OS) Quality of life scores ECOG performance status scores Surgical incision healing scores Adverse Events (AEs)
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for the trial:
1. Female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer;
2. Early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest ASCO/CAP guidelines, meeting the following conditions:Axillary lymph node biopsy-positive;ECOG performance status score of 0-1;
3. Presence of at least one measurable lesion based on RECIST 1.1 criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant radiotherapy
receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy
No interventions assigned to this group
Neoadjuvant radiotherapy
receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Neoadjuvant radiotherapy
The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Interventions
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Neoadjuvant radiotherapy
The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed breast cancer;
* Axillary lymph node biopsy-positive;
* ECOG performance status score of 0-1;
Exclusion Criteria
* inflammatory breast cancer;
* Pregnancy and Lactation;
18 Years
65 Years
FEMALE
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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Xijing hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WZ-1
Identifier Type: -
Identifier Source: org_study_id
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