NCT05479409

Neoadjuvant Radiation in Locally Advanced Breast Cancer

Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether neoadjuvant radiation therapy is effective in improving local-regional control and to explore predictors of response to treatment in inoperable breast cancer patients after 2-6 courses of neoadjuvant chemotherapy.

Detailed description

RATIONALE: The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. It is currently accepted that the administration of radiation therapy prior to surgery might result in higher surgery rate or improvement of clinical outcomes. OUTLINE： This is a prospective phase II study. The purpose is to evaluate the effectiveness of neoadjuvant radiotherapy in combination with chemotherapy. The primary objective in this study is to assess clinical outcomes of these patients. A secondary objective in this study is to identify biomarkers and imaging parameters that can be used as early predictors of treatment response in women with locally advanced breast cancer. Fresh tumor tissue or fresh peripheral blood should be collected as the test sample and stored before treatment. Ultrasound spectroscopy including shear wave elastography parameters should be done before and after treatment.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
RADIATION	Neoadjuvant radiotherapy	radiation therapy combined with chemotherapy prior to surgery

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2022-07-29
• Last updated: 2022-07-29

Locations

1 site across 1 country: China