Neoadjuvant Radiation in Locally Advanced Breast Cancer
About this study
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.
- Condition
- Breast Neoplasms
- Tested
- Neoadjuvant radiotherapy, β-alanine, Spatially fractionated radiotherapy
- Sponsor
- Fudan University
Who can join
- Age
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Maximum age: 70 years
- Eligible sex: Female
- Study condition: Breast Neoplasms
- 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
Exclusion 5
- 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
1 site, 1 recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Contact
-
Xiaoli Yu
+86-021-64175590 xiaoliyu@fudan.edu.cn
-
Jin Meng
+86 18121299532 jinmeng@fudan.edu.cn
Potential match only. Final eligibility is determined by the study team.