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RECRUITING
NCT05479409
PHASE2

Neoadjuvant Radiation in Locally Advanced Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant radiation therapy in improving local-regional control and facilitating surgical conversion in patients with inoperable locally advanced breast cancer after 2-6 courses of neoadjuvant chemotherapy. This study will also investigate whether beta-alanine supplementation and spatially fractionated radiotherapy can enhance the therapeutic response to neoadjuvant chemoradiotherapy. In addition, this study aims to explore tumor microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-03-01

Completion Date

2027-12

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

RADIATION

Neoadjuvant radiotherapy

The preoperative radiation dose will be 50 Gy in 25 fractions to the breast and regional lymph node PTV, followed by surgical evaluation. Operable patients will proceed to surgery; inoperable patients will continue radiotherapy to 60 Gy in 30 fractions, with residual breast and nodal lesions boosted to 66 Gy in 33 fractions.

DIETARY_SUPPLEMENT

β-alanine

β-alanine, 1.7g, tid, p.o

RADIATION

Spatially fractionated radiotherapy

Spatially fractionated radiotherapy will be delivered as a lattice radiotherapy boost. The high-dose gross tumor volume (GTV) will receive 15 Gy in 1 fraction. The conventional clinical target volume (CTV), including the ipsilateral breast and regional lymphatic drainage area, will receive 40.05 Gy in 15 fractions. The boost volume, if applicable, including positive lymphatic drainage areas, will receive an additional 10 Gy in 5 fractions.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China