Neoadjuvant Radiation in Locally Advanced Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT05479409
- Run by
- Fudan University
- People needed
- 70
- Starts
- 2021-03-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed locally advanced breast carcinoma
- Inoperable with with 4-6 courses of prior chemotherapy
- No contradiction of radiation or chemo-radiotherapy
- Patients should have the ability to understand and the willingness to sign a written informed consent document
- Signed informed consent must be obtained prior to any study specific procedures
You may not qualify if…
- Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
- Coagulation disorders
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
- Serious underlying medical illness with life expectancy less than 2 years.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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