NCT06697938

Neoadjuvant Chemoradiotherapy Compared to Neoadjuvant Chemotherapy for Luminal-Type Locally Advanced Breast Cancer: A Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Preoperative SBRT for the Primary Lesion of Breast Cancer	SBRT for Primary Lesion of Breast Cancer, Radiation Dose: Primary Lesion ≤3 cm, GTV 24Gy/3F; Primary Lesion \>3 cm, GTV 30Gy/5F.

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: China