An interventional study of Preoperative SBRT for the Primary Lesion of Breast Cancer in Breast Cancer, sponsored by Sichuan Cancer Hospital and Research Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Sichuan Cancer Hospital and Research Institute · Not applicable, Interventional, and Treatment
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.
Breast cancer is a tumor with high tumor heterogeneity, and treatment outcomes vary significantly across different molecular subtypes. In recent years, the emergence of novel treatment methods has significantly improved the overall survival and progression-free survival of patients with early-stage, especially metastatic tumors. However, a portion of patients with locally advanced breast cancer (LABC) still have poor prognoses. As early as the 1970s, preoperative radiotherapy was applied to locally advanced breast cancer to increase resectability, but due to limitations in radiotherapy techniques and other factors, preoperative radiotherapy increased the incidence of acute toxic reactions and postoperative complications. Compared to traditional postoperative radiotherapy, neoadjuvant radiotherapy has several theoretical advantages, such as more precise tumor target localization, optimization of breast reconstruction radiotherapy strategies, increased tumor downstaging to improve breast-conserving surgery opportunities, and improved pathological complete response rates, potentially eliminating the need for breast surgery. With the advent of the era of precision radiotherapy, modern radiotherapy technologies have provided solutions to reduce the acute toxic reactions associated with preoperative radiotherapy. This study focuses on preoperative treatment modalities for luminal-type locally advanced breast cancer. 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 these patients. The goal is to provide new strategic options for the preoperative treatment of luminal-type locally advanced breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 148 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sichuan Cancer Hospital and Research Institute is the lead sponsor of 62 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative umor SBRT and surgery after Neoadjuvant Chemotherapy
Radiation: Preoperative SBRT for the Primary Lesion of Breast Cancer
Surgery after Neoadjuvant Chemotherapy
SBRT for Primary Lesion of Breast Cancer, Radiation Dose: Primary Lesion ≤3 cm, GTV 24Gy/3F; Primary Lesion \>3 cm, GTV 30Gy/5F.
pCR
Pathological Complete Response Following Surgery
Time frame: From enrollment to one month after surgery
Breast Conserving Surgery Rate
Comparison of Breast Conserving Surgery Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
Time frame: From enrollment to the completion of surgery
PFS
Comparison of 3-Year Progression-Free Survival (PFS) Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
Time frame: From enrollment to the completion of the 3-year follow-up period
Adverse Event Incidence Rate
Comparison of Adverse Event Incidence Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups
Time frame: From enrollment to the completion of the 3-year follow-up period
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sichuan Cancer Hospital and Research Institute