Clinical trial NCT06769919: A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
Official title: A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: radiotherapy
system therapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
Primary purpose: TREATMENT

Brief summary: A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.

Detailed description: This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.

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.

Eligibility criteria: Inclusion Criteria:

* Female patients aged ≥18 years and ≤65 years；
* newly diagnosed breast cancer;
* Axillary lymph node biopsy-positive;
* ECOG performance status score of 0-1;

Exclusion Criteria:

* metastatic breast cancer or bilateral breast cancer;
* inflammatory breast cancer;
* Pregnancy and Lactation;

Primary outcomes:
measure: Residual Cancer Burden (RCB) 0/I
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: From enrollment to 10 years later or death.
measure: Invasive Disease-Free Survival (iDFS)
timeFrame: From enrollment to 10 years later or death.
measure: Overall Survival (OS)
timeFrame: From enrollment to 10 years later or death.
measure: Quality of life scores
timeFrame: From enrollment to 3 years after treatment completion.
measure: ECOG performance status scores
timeFrame: From enrollment to 3 years after treatment completion.
measure: Surgical incision healing scores
timeFrame: From enrollment to 1 years after treatment completion.
measure: Adverse Events (AEs)
timeFrame: From enrollment to 3 years after treatment completion.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References: