Neoadjuvant Radiation in Locally Advanced Breast Cancer
ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Neoadjuvant radiotherapy
- β-alanine
- Spatially fractionated radiotherapy
Treatment groups
70 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov