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Brief Title: Neoadjuvant Radiation in Locally Advanced Breast Cancer
Official Title: Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Study ID: NCT05479409
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Xiaoli Yu
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR