About this trial
This study focuses on preoperative treatment modalities for luminal-type locally advanced breast cancer. Based on modern precision radiotherapy technologies such as MRI-Linac, CyberKnife, and VMAT, it aims to compare the pCR rate, breast conserving surgery (BCS) rate, progression-free survival (PFS), and treatment-related side effects between preoperative neoadjuvant chemotherapy and preoperative neoadjuvant SBRT combined with chemotherapy in patients with this type of breast cancer. The goal is to provide new strategic options for the preoperative treatment of luminal-type locally advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed invasive breast cancer ;
Breast MRI showing stages IIB to IIIC (2017 AJCC 8th edition staging);
Clinical staging confirmed by chest MRI and/or axillary ultrasound, as well as CT scans of the neck, abdomen, and pelvis, and bone scintigraphy, including T and N staging and assessment of distant metastasis;
Karnofsky performance score ≥80 or ECOG performance status of 0-1;
Disqualifiers
History of malignancy at other sites, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
Inability to complete MRI;
Inflammatory breast cancer;
Bilateral or multifocal primary tumors;
Trial design
Parallel
Treatments tested in this trial
Preoperative SBRT for the Primary Lesion of Breast Cancer
RadiationSBRT for Primary Lesion of Breast Cancer, Radiation Dose: Primary Lesion ≤3 cm, GTV 24Gy/3F; Primary Lesion \>3 cm, GTV 30Gy/5F.
Treatment groups
Trial outcomes
Primary outcomes
pCR
Pathological Complete Response Following Surgery
Secondary outcomes
Breast Conserving Surgery Rate
Comparison of Breast Conserving Surgery Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
PFS
Comparison of 3-Year Progression-Free Survival (PFS) Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
Adverse Event Incidence Rate
Comparison of Adverse Event Incidence Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
Sponsors and contacts
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